CBI s 14 th ANNUAL PRODUCT COMPLAINTS CONGRESS FOR LIFE SCIENCES June 14, 2016

Transcription

1 CBI s 14 th ANNUAL PRODUCT COMPLAINTS CONGRESS FOR LIFE SCIENCES June 14, 2016 UPDATE ON FDA GUIDANCE AND REGULATIONS FOR THE COMPLAINT HANDLING PROCESS AND ON FDA FIELD ALERT REPORTS By Peter S. Reichertz Partner Sheppard Mullin Richter & Hampton, LLP preichertz@sheppardmullin.com Sheppard, Mullin, Richter & Hampton LLP 2013

2 AGENDA Explore FDA complaint handling requirements Address and align complaints, adverse events and field alerts Insights into FDA s focus during investigations Analyze recent enforcement trends and regulatory changes 2

3 FDA COMPLAINT HANDLING REQUIREMENTS Drugs 21 C.F.R Medical Devices 21 C.F.R

4 FDA COMPLAINT HANDLING REQUIREMENTS DRUGS: Written procedures written and complaints Review by a Quality Control Unit Determination of need for an investigation Determination as to whether complaint is an adverse event that needs to be reported to FDA Conducting an investigation to determine root cause of reason for complaint Corrective and Preventive Action 4

5 FDA COMPLAINT HANDLING REQUIREMENTS DRUGS: Records: Must keep a written records of each complaint and investigation in a designated complaint file Must keep readily available Must keep for one (1) year beyond expiration date of product or one (1) year after complaint received, whichever is longer 5

6 FDA COMPLAINT HANDLING REQUIREMENTS DRUGS: Records shall Include: Name and strength of drug product Lot number Name of complainant Nature of complaint Reply to complainant Findings of investigation and follow-up If no investigation conducted, the reason why no investigation was undertaken and the name of the responsible person making the decision 6

7 FDA COMPLAINT HANDLING REQUIREMENTS DEVICES: Maintain complaint files Establish and maintain procedures for receiving, reviewing and evaluating complaints Complaints reviewed by a formally designated unit 7

8 FDA COMPLAINT HANDLING REQUIREMENTS DEVICES Procedures shall: Require complaints to be processed and reviewed in a timely manner Document oral complaints upon receipt Require a determination to be made as to whether the complaint is an event which is required to be reported as a Medical Device Report (MDR) Require a determination be made as to whether an investigation is necessary and, if no investigation is needed, the name of the responsible person making the decision 8

9 FDA COMPLAINT HANDLING REQUIREMENTS DEVICES Requirement of an investigation if failure to meet any of specifications or possible failure of the device (unless there was a prior investigation of similar complaint and another investigation is not necessary) MDR reports must be reviewed, evaluated and investigated by a designated individual investigation to include: Whether device failed to meet specifications Whether device being used for treatment or diagnosis Relationship of device to incident/adverse event 9

10 FDA COMPLAINT HANDLING REQUIREMENTS DEVICES Investigations Records shall include: Name of device Date complaint received UDI/UPC/or other identifier Name, address and phone number of complainant Nature and details of complaint Dates and results of investigation Any corrective action taken Reply to the complainant 10

11 FDA COMPLAINT HANDLING REQUIREMENTS DEVICES RECORDS Kept by the formally designated unit At the manufacturing facility, or otherwise readily accessible Kept for design and expected life of the device but in no case for less than two (2) years after commercial release for distribution 11

12 COMPLAINT HANDLING BEST PRACTICES Complaint Handling SOP should: Provide for initial determination of type of complaint and of possible safety issues Prioritize handling of complaints that represent potentially significant safety issues or anything that might require an NDA Field Alert Report/Product Correction/Removal or an ADE/MDR filing. Notification to management of priority complaints Notification to Quality Personnel/Quality Committee Referral for Investigation. Notifications to Complainant. Close out of Complaint File 12

13 COMPLAINT HANDLING BEST PRACTICES Investigations SOP should: Provide for expeditious initial review of priority complaints Review of retain samples of lot/lots affected. Review of lots that might be affected lots made just before or after affected lots. Determination of root cause Timetable for completion. Preparation of Report. 13

14 COMPLAINT HANDLING BEST PRACTICES Recall SOP should include: Process for review and evaluation of priority complaints Specify persons on Recall Quality Committee or persons involved in determining whether a recall should be conducted Provide for a medical assessment of potential patient risk Assessment of need for recall and depth of recall Reporting to FDA Handling of recall Recall Effectiveness Checks Termination of recall 14

15 COMPLAINT HANDLING BEST PRACTICES Medical assessment is critical. Why? Need to be able to document that risk to patients adequately evaluated and that complaint evaluated to determine if adverse event/mdr involved, and, if so relatedness, and degree of risk FDA may request a medical assessment from the company Substantiates adequacy of a company s actions and helps protect from product liability claims. 15

16 COMPLAINT HANDLING BEST PRACTICES Medical Assessment should include: Whether any disease or injuries have already occurred from the use of the product. Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion should be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion o the individual(s) making the health hazard determination. Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be a greatest risk. Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed Assessment of the likelihood of occurrence of the hazard Assessment of the consequences (immediate or long-range) of occurrence of the hazard. 16

17 COMPLAINT HANDLING BEST PRACTICES Have a designated complaint unit / dedicated personnel Have detailed SOP regarding handling of complaints that prioritizes complaints that may be ADE/MDR reportable Make sure all relevant information collected and kept in file. Have a procedure to make sure all possible sources of complaints are reviewed (i.e., websites) Segregate and maintain separate complaint files designated as such / have personnel dedicated to maintain files 17

18 COMPLAINT HANDLING BEST PRACTICES Conduct training/retraining of personnel, particularly sales representatives/customer service personnel on an annual basis, to ensure compliance with requirement to report complaints. Have a detailed, but easy to use, complaint intake form that includes all required information so follow-up reduced Review status of complaints/investigations on a routine (weekly?) basis to ensure timelines met 18

19 COMPLAINT HANDLING BEST PRACTICES Conduct periodic reviews of complaints, evaluate, trend and share results with management/legal Review complaints, status of investigations, and CAPA s in scheduled Quality Committee Meetings Advise management of complaints trending and significant issues in periodic Management Meetings Conduct periodic internal auditing of complaint handling function. 19

20 COMPLAINT HANDLING BEST PRACTICES Make sure record retention policy in effect such that complaint files destroyed when they can be. Make sure product not subject to litigation/litigation hold before destroying any documents Make sure have pharmacovigilance agreements or language in distribution agreements in place with distributors that require reporting of complaints/ades/mdrs 20

21 COMPLAINT HANDLING BEST PRACTICES Summary: Be concise but complete Follow-up Have procedures in place Have dedicated personnel Involve Legal/Medical where necessary Document everything and segregate files! 21

22 FIELD ALERT REQUIREMENTS NDA/ANDA/BLA Field Alert Reports Required when there is any: Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article. Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application. 21 C.F.R (b)(1) 22

23 FIELD ALERT REQUIREMENTS NDA/ANDA/BLA Field Alert Reports Requirements: Report to local FDA District Office Within 3 working days of receipt of information Can be telephoned in / but must be followed up by written report Report/Mailing Cover Must Specify NDA-Field Alert Report Form FDA 3331 or 3331a (Automated) 23

24 FIELD ALERT REQUIREMENTS NDA/ANDA/BLA Field Alert Reports What should be included: Brief description of information received Brief description of any preliminary investigation Evaluation, if any, of possible corrective/preventative action Timetable for investigation/communicating additional information to FDA Contact person/contact information 24

25 FIELD ALERT REQUIREMENTS NDA/ANDA/BLA Field Alert Reports Caveats: Be factual Do not speculate Remember every record could be used against you by FDA or in product liability litigation Be prepared many NDA Field Alert Reports result in an immediate visit from the local FDA District Office Evaluate if information is an ADE/MDR that must be separately reported. 25

26 FIELD ALERT REQUIREMENTS NDA/ANDA/BLA Field Alert Reports For medical devices: No similar requirement But device malfunctions are potentially reportable MDRs, and must be evaluated as such. Same requirements apply. But See 21 C.F.R. 806 Reports of corrections and Removals 26

27 FIELD ALERT REQUIREMENTS Reports of corrections and removals. (a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated: (1) To reduce a risk to health posed by the device; or (2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b). (b) The manufacturer or importer shall submit any report required by paragraph (a) of this section within 10-working days of initiating such correction or removal. NOTE: Must keep record of removal/corrections not reported with FDA along with justification as to why not submitted. 27

28 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS DRUGS EVALUATION OF COMPLAINTS: Adverse Event? Serious? Unexpected? Reportable Adverse Event? Need to file an NDA field alert? Failure to meet specifications chemical, physical? Mislabeling? Need for a recall? 28

29 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS DEVICES EVALUATION OF COMPLAINTS: Product malfunction? Death or serious injury if were to recur? Caused or contributed to death or serious injury? Reportable MDR? Need to conduct a removal or correction? Need to report to FDA? Need to conduct a recall? 29

30 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Complaints can be both a complaint and adverse event/mdr if: Product failure to meet specifications or malfunction Results in injury or death to patient For drugs, lack of effectiveness is both a complaint and an adverse event (failure of expected pharmacological action) 30

31 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. ADEs/Drugs: If serious/unexpected, whether foreign or domestic, report 15 calendar days after of receipt of initial information of ADE Follow-up information 15 calendar days of receipt of any new information of previously reported ADE If not serious/expected, submit in periodic adverse experience report (Note: can obtain waiver regarding reporting of non-serious/expected ADEs). 31

32 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. MDRs/DEVICES: 5 working days of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health. 30 calendar days of report that a device caused or may have caused or contributed to death/serious injury or malfunction, if recurrence of malfunction likely to cause or contribute to a death or serious injury. 32

33 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. Recalls: Most recalls are voluntary actions. FDA limited authority to order recalls for drugs. For devices, FDA has authority to order recalls. See 21 C.F.R No legal requirement to notify FDA of a voluntary recall for drugs In most cases market withdrawals being an exception advising FDA of a recall is advisable. Regulatory reasons Legal/product liability reasons. 33

34 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. Devices Reports of correction / removals: If a manufacturer undertakes an action to correct or remove a device from the market to reduce a health risk or remedy a violation that could lead to health risk, must report to FDA within 10 working days of initiating removal/correction. Must keep records of corrections/removals that do not meet the criteria for 10 day reporting. See 21 C.F.R

35 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. ADEs/MDRs: Report to FDA for time period required after receipt of reportable information 5 or 30 days if MDR 15 or periodic if ADE Follow-up reports-same time requirements 35

36 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. Recalls: No specific time requirement Once decision has been made Do not need to await FDA input to commence recall FDA will categorize level of recall I, II or III after recall notice submitted but it may take weeks or months. Most recalls voluntary; some mandatory 36

37 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. Notices of Corrections/Removals (Devices): Within 10 days of initiating correction or removal FDA does not need to be notified before commencement of action 37

38 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Determining When to Report ADEs / MDRs or Recalls to FDA. Advice: When in doubt report Little downside to reporting Disclaimers on 3500A re connection of event causality to device or drug Product liability protection 38

39 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Process and Personnel for Communication to FDA Complaints: Not reportable to FDA unless meet requirements of an NDA Field Alert Report or MDR/ADE NDA Field Alert Reports may be telephoned in to local FDA District Office but must be followed up by written report Advice: Unless truly exigent circumstance, submit only in writing No requirement as to whom should submit, but usually submitted by Regulatory Affairs Regulatory Affairs dedicated person should be responsible for collecting information from Complaint intake, QA and other personnel involved in intake and investigation of complaints 39

40 ALIGN COMPLAINTS, ADVERSE EVENTS AND FIELD ALERTS Process and Personnel for Communication to FDA MDRs / ADEs: Should be submitted in writing on MedWatch Form 3500A to appropriate address depending on product type Usually Medical Affairs / PV department prepares 3500A based on PV intake Usually Regulatory Affairs submits MDR / ADE reports and periodic reports. ADEs / MDRs part of NDA/PMA application file. 40

41 FDA s FOCUS DURING INVESTIGATIONS Are complaint procedures in place? Are they followed? Do they include oral complaints? Is there a formally designated unit to review complaints? Are there formally designated complaint files? Are complaints evaluated for need to report as an ADE/MDR? Were complaints reviewed to determine if an investigation was necessary? Were efforts to obtain information from complainants needed to conduct an evaluation performed/documented? 41

42 FDA s FOCUS DURING INVESTIGATIONS If no investigation was conducted, was the rationale for not conducting an investigation documented? Does the complaint file include all records relating to the investigation of the complaint? Was a root cause identified? Were the complaint investigations concluded? Were complaints reviewed in a timely manner? Was need for corrective action evaluated? Was trend analysis conducted? 42

43 FDA s FOCUS DURING INVESTIGATIONS NDA/ANDA/BLA Field Alerts Were complaints evaluated for the need to file a Field Alert report? Were Field Alert reports filed on a timely basis? Did the Company keep FDA informed as to the investigation into the complaint that led to the Field Alert report and was the investigation/action adequate? Was Management made aware of Field Alerts? Were Field Alerts closed? 43

44 RECENT ENFORCEMENT Hospira Spa Warning Letter, March 31, 2015 For example, your firm failed to conduct a thorough investigation for 103 complaints for (b)(4) injection related to discoloration of (b)(4) or (b)(4) solution between November 1, 2011 and October 31, 2013, and a more recent complaint on April 3, Many customer complaints have stated that the product changed to a (b)(4) color, rather than the normal (b)(4) appearance. You concluded that the root cause for the discoloration was the (b)(4) of the product. Your investigation is inadequate because you failed to evaluate the impact that (b)(4) may have on the quality of the product and to correlate the level of (b)(4) degradant with the amount of discoloration observed. Your investigation also failed to consider that the discoloration might have been caused by the failure to perform a step in the manufacturing process in an (b)(4) environment. Specifically, you mention that some vials may have (b)(4) as a result of them (b)(4) shelf during the stoppering manufacturing phase. You state that the unloading of the vials from the (b)(4) to (b)(4) is not performed (b)(4) and that there is a potential for (b)(4) ingress. We acknowledge your commitment to continue the investigation of (b)(4) levels in (b)(4) vials per protocol KC3601-ENG. However, your response does not adequately address the impact of the effect of (b)(4) in that your medical assessment lacks an evaluation of whether the degradant poses a risk to patients. 44

45 RECENT ENFORCEMENT Sorin Group Deutschland GmbH December 29, Failure to adequately develop, implement, and maintain written MDR procedures, as required by 21 CFR (Arvada facility). For example: a. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits definition of the term reasonably suggests, found in (c)(1). The exclusion of this definition for this term from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR (a); b. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the procedure does not address how your firm will submit all information reasonably known to it for each event; c. The procedure does not describe how it will address documentation and record-keeping requirements, including: i. Documentation of adverse event related information maintained as MDR event files ii. iii. iv. Information that was evaluated to determine if an event was reportable; Documentation of the deliberations and decision-making processes used to determine if a devicerelated death, serious injury, or malfunction was or was not reportable; and Systems that ensure access to information that facilitates timely follow-up and inspection by FDA. 45

46 RECENT ENFORCEMENT Shasta Technologies, Inc. Warning Letter April 8, 2014 Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). Specifically, no complaint handling procedures were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have complaint handling procedures although he reviews consumer reviews on the internet and thus is conducting complaint handling activities for Shasta. 46

47 RECENT ENFORCEMENT EPS Biotechnology Corp. Close Out Letter October 31, 2012 Your firm failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). For example: Procedures establishing the receipt of complaint information from the complainant have not been defined and established in agreements with the United States distributor, Oak Tree International Holdings, who will provide the service of receiving all US based customer complaints and providing this data to EPS Bio Technology. Review of (b)(4) complaints files revealed that the files contained a complaint description but did not contain documentation of complaint information being collected in accordance with a procedure establishing the nature and details of the complaint such as users involvement or impact on the users or evaluation for MDR reporting. 47

48 RECENT ENFORCEMENT Pinook USA Warning Letter June 14, 2012: Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). For example: when the investigator asked to review your firm s complaint handling procedures, your firm s management stated that the company does not have complaint handling procedures. We reviewed your firm s response and conclude that it is not adequate. Your firm stated that it has reviewed and revised its complaint handling procedure to include references to 21 CFR 803 Medical Device Reporting (MDR). However, it is unclear if adequate written complaint handling procedures have been implemented, as your firm s management was unable to provide them to the investigator upon request. 48

49 RECENT ENFORCEMENT Atossa Genetics, Inc. Warning Letter February 20, Failure to maintain adequate complaint files and to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). For example, when asked by the investigator, Mr. (b)(4), your firm s Regulatory Consultant, indicated that you have not established complaint handling procedures and that you do not have a formally designated unit for handling complaints. Your firm received a complaint in December 2011 and another in January 2012, concerning thread breakage of the MASCT System funnel; however, the complaints were not maintained in a complaint file. We reviewed your firm s response and conclude that it is not adequate. While a procedure titled SOP-009, Customer Complaints was submitted in your response, no evidence of implementation or training on this procedure was provided. In addition, you did not provide evidence that you created a complaint file to include all complaints as required as a correction to this observation, nor did you indicate you retrospectively reviewed all complaints to ensure they were received, reviewed and evaluated as required as a corrective action to this observation. 5. Failure to maintain an adequate record of investigation by a formally designated unit when an investigation is made under 21 CFR , as required by 21 CFR (e). For example, your firm received a complaint in December 2011, and another in January 2012, concerning thread breakage of the MASCT System funnel; however, the record of investigation for these complaints did not include all required information, such as the exact date a complaint was received, the address and phone number of the complainant, dates and results of the investigation, and correspondence with the complainant. 49

50 RECENT ENFORCEMENT Biomerieux Inc. Warning Letter October 10, Your firm failed to adequately review and evaluate all complaints to determine whether an investigation was necessary, as required by 21 CFR (b). Specifically, your complaint handling process is inadequate in that: a. Your firm closed 18,926 complaints with associated service orders between 1/1/2013 and 7/15/2014 documenting the replacement of failed components without conducting a thorough investigation to determine why the component failed. Your complaint investigation stopped when the component was replaced. The investigation did not include attempting to determine if the failure was due to design, production, supply, or assembly issue or due to some other quality issue. The investigation did not extend to assessment of the extent of failure in other devices or whether the failure was occurring in other families of devices. There was no documentation that a determination was made that no investigation was necessary and a reason given why an investigation was not necessary. b. Your firm closed 6,861 complaints between 1/1/2013 and 7/21/2014 with no documentation of an investigation being conducted or a determination that no investigation was necessary and a reason why no investigation was conducted. 50

51 RECENT ENFORCEMENT Riverpoint Medical Warning Letter May 1, Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). For example, your Complaint Handling Procedure, , effective August 16, 2012, does not require communications alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of the MedLED TM line of headlamps be handled as a complaint unless the device is under warranty. The intended use of MedLED TM devices is to provide light during surgical procedures. Our investigator reviewed five Returned Goods Authorizations for MedLED TM devices in which he observed 17 device issues, such as exposed battery pack wiring and wiring shorts, which were not identified or handled as complaints. Additionally, you did not record the complainant contact information or evaluation of MDR reportability as required by the regulations. 51

52 RECENT ENFORCEMENT Nephros Inc. Warning Letter May 27, Failure to include required information in your records of complaint investigations as required by 21 CFR (e). For example, your SOP 8.2.1, Customer Feedback, Complaint Handling & Monitoring, dated 01/23/2014, Section 9.5, states that the initial investigation shall be documented on the customer complaint form and, based on the nature of the complaint, must include: evaluation of the returned product or inventory retention samples; review of in-house device history records; review of shipping records; review of complaint trends; review of risk controls; and/or review of product labeling. Your complaint investigations were observed to be inadequate in that they were lacking critical information, as evidenced by the following customer complaints including, but not limited to: a) # : Complaint involved the In-Line Dual Stage Ultrafilter (DSU) which had bacterial and endotoxin counts at the machine post filter. The investigation failed to include label reviews, inventory analysis, and trend analysis. b) # : Complaint involved the In-Line Single Stage Ultrafilter (SSU) which had a filter leak around the spout. The investigation failed to include label reviews, inventory analysis, and trend analysis. c) # : Complaint involved the OLpur H2H Hemodiafiltration Module Substitution Filter which failed an integrity test on the module. The investigation failed to include DHR review, inventory analysis, and trend analysis. 52

53 RECENT ENFORCEMENT VUAB Pharma, Inc. Warning Letter May 27, Failure to adequately investigate and resolve all quality-related customer complaints, and to investigate other batches that may have been associated with specific failures. 53

54 RECENT ENFORCEMENT Apotex, Inc. Warning Letter June 16, Failure to include adequate documentation during complaint investigation. Your firm received complaint #(b)(4) for (b)(4) USP batch #(b)(4) due to failing assay results. The original investigation, approved on March 29, 2013, indicated that the complaint was received on February 26, During the review of that investigation, our investigators found a test record from January 8, 2013 (prior to the date you documented receiving the complaint) that reported failing HPLC assay results of the retain sample of batch (b)(4). This record was not included in the investigation report. Your response to the Form FDA-483 observation included an addendum to the investigation report that indicated the complaint/query was actually received on January 8,

55 RECENT ENFORCEMENT Osachi, Inc. Warning Letter November 13, Failure to maintain adequate complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR (a). For example: Your firm s Customer Complaint Handling SOP, Defect Report Notification, Doc. No. 029, Version B-1.10, and your firm s complaint handling form do not require that complaints be evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR 803, Medical Device Reporting. 55

56 RECENT ENFORCEMENT Smith & Nephew, Inc. Warning Letter June 11, Failure to evaluate and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR (c). For example: a. Your firm has not established and maintained Section 7.1 of its Complaint Handling Procedure, C-10, which requires follow up with the complainant in order to collect any additional information required for the evaluation. The complaint records do not document an attempt to collect the additional information. b. Your firm has not established and maintained Section of its Complaint Handling Procedure, C-10, which requires a Risk Assessment Review for complaints that are adverse events or lead to a potential hazard. Seventeen complaint records were observed that covered alleged pooling and/or lack of alarm function for the Renasys EZ/EZ Plus device in which your firm documented known hazards. However, ten of the seventeen records did not document review of the risk assessment for the device. c. Your firm has not established and maintained Section of its Complaint Handling Procedure, C-10, which requires notification of the Risk Management Group of any hazard or harm not previously evaluated, or when there has been an increase in the risk residual rating established. Your firm was unable to provide documentation that supports the Risk Management Group was notified of the increase in the risk residual rating for the Maceration hazard from a loss of vacuum pressure at the wound site described in complaint

57 ENFORCEMENT TRENDS/REGULATORY CHANGES No discernable recent trend Since QSIT technique adopted, much more focus on Complaint handling Investigations Management Review/Management Investment in Quality Complaint handling and SOP s likely to continue to be major focus of cgmp/qsr inspections Good procedures, processes and records highly indicative of a good quality system and dedication to quality and customers. 57

58 QUESTIONS? 58