Connie Hoy October 2013

Transcription

1 Connie Hoy October 2013

2 Warning letter issued to firm for complaint handling Failure to report within 30 days Failure to implement adequate procedures Failure to establish standard review process No procedure on how to fill out a 3500A Compliant SOP did not contain the address to send the 3500A Failure to properly identify the designated unit

3 No definition of a reportable event in the procedure No documentation on how the decision to report or not report is made No method for adequate follow up No corrective actions taken Failure to maintain adequate information in complaint files

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6 Not aware of regulations Intentionally didn t file in order to hide serious adverse events Forgot

7 COMPANY BELIEVED THEY WERE IN COMPLIANCE

8 Failure to report within 30 days Failure to implement adequate procedures Failure to establish standard review process No definition of a reportable event in the procedure No documentation on how the decision to report or not report is made No method for adequate follow up No corrective actions taken Failure to maintain adequate information in complaint files

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10 International Organization Management OUS Headquarters OUS Mfg OUS OPS OUS Marketing OUS Engineering OUS Designated Unit OUS RA/QA OUS Management Rep Doc Control OUS

11 US Operation US Subsidiary US Call Center Sales in US

12 Subsidiary establishment listing was for Manufacturer

13 Manufacturers of medical devices are required to report a device-related death, serious injury, or malfunction within 30 days after becoming aware of the event. Manufacturers are required to establish and maintain files related to reportable events. Manufacturers must develop, implement, and maintain written procedures for reporting adverse medical device events.

14 No agreement or procedure between the headquarters and the subsidiary that showed responsibility for complaints, adverse event investigation, reporting

15 Complaint handling procedures did exist but only at the headquarters level Due to the time difference, the US office could not obtain the procedures until the 2 nd day of the inspection US Call Center personnel were not aware of the existence of procedures

16 Procedures were not written in English This is amajor prob lem And they got inaal skdjqo tyrueieop Poer ywuqtiv

17 When US call center was asked what they do when they become aware of a potential adverse event they replied: I tell the General Manager (a sales person) When General Manager was asked for next step he replied: I headquarters

18 No AE Event files to review because they were located in a foreign country Took another day to get a list of investigated AE Took another day to get copies of the files Files were not written in English

19 Some of the Adverse events were filed late >30 days

20 What is the best way to prevent a warning letter?

21 DO NOT GET A 483

22 Importer - Takes first title to devices imported into the U.S. An Initial Importer must have a U.S. address (21 CFR ) Distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

23 FDA Inspector came to facility expecting to find a manufacturer with meeting all Quality System and regulatory Requirements Importers and distributors may be able to obtain MDR exemption

24 Apply for an MDR Exemption FDA may, upon written request or at its own discretion.grant to user facilities or manufacturers an exemption, variance, or alternative form of reporting from any or all of the reporting requirements Medwatch regulation(8)

25 Complaint handling procedure in English Relationship with US office to Hq Role of US call center Role of Designated Unit Basic, documented training for Call Center / Sales people on adverse events Script of questions for obtaining immediate Information (form) Timeframe to report AE to designated unit

26 Copy (paper or ecopy) of investigations 21 CFR (g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either: (1) A location in the United States where the manufacturer's records are regularly kept; or (2) The location of the initial distributor

27 Designated unit in US office Procedures (English) for complaint handling and AE investigation Original files in US office Copy sent to HQ

28 Jump into action Changed their establishment type Applied for an exemption from reporting Had the Designated unit (OUS) file the late MDRs Provided Corrective action with in 10 days SOPs in English defining a compliant process Form for collecting AE information during call point Training Records for Call Center

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30 Received an exemption from MDR Reporting Sent copy of the exemption approval to the District Office

31 160 Days had passed since the initial 483 was issued 145 Days had passed since the initial response was sent to the district office

32 Corrective Action was insufficient Response was inadequate They were given an exemption for the very thing they now had received the warning letter

33 When they received the exemption they should have: Sent a written reply to the District Office Asked for a meeting with the District Office Sent a written reply to the Office of Compliance Asked for a meeting with the Office of Compliance All of the above

34 This should have prevented the WL, right? Should they ask to have the WL Rescinded?

35 Is receiving an exemption for MDR Reporting adequate corrective action? My opinion: NO The exemption is for MDR Reporting because FDA is not interested in duplicate reporting It is NOT an exemption from complying with the regulation itself This company was not in compliance with the regulations as stated in 21 CFR 820

36 Doesn t really matter who files the piece of paper to the FDA The most important tasks are: Adequate investigation of the AE Identifying the root case Taking corrective action / preventive action Correct management of reportable events Good documentation that is available to the FDA

37 Can these tasks be adequately performed by a designated unit that is OUS?

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40 Well trained designated unit OUS Well defined process for investigation Well defined communication with the US office and the designated unit Adequate investigation leading to root cause and closure Availability of records to present to FDA (electronic) Link to Well Defined CAPA program

41 Well trained designated Unit in US Well defined process for feedback to headquarters Well defined process for investigation Well defined communication with the US office and the designated unit Adequate investigation leading to root cause and closure Availability of records to present to FDA (electronic) Link to Well Defined CAPA program

42 Designated Unit should remain OUS US office does not have appropriate technical capability to investigate

43 US office is only a sales office and call center Sales calls come into the office Sometimes report of an adverse event Sales people work out of this office Sometimes get report of an adverse event Ad hoc activity on how this gets handled Investigation is thwarted Time zone Language No gathering of initial information

44 FDA Inspector came to inspect manufacturer No procedures available and had to wait until day 2 to get SOPs SOPS not in English so they were verbally translated by the General Manager No records showing any type of investigation Investigator had to wait for copy of compliant files and they were not in English

45 Response contains a real solution to the handling of adverse events Exemption from filing an MDR Communication with the District office and Office of Compliance

46 DITTO

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