AMENDED WARNING LETTER CIN

Transcription

1 Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH Telephone: (513) FAX: (513) August 13, 2012 Via United Parcel Services John Parrillo, Owner Parrillo Performance 6200 Union Center Boulevard Fairfield, Ohio Dear Mr. Parrillo: AMENDED WARNING LETTER CIN Between February 13, 2012 and February 29, 2012, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing and re-packaging facility located at 6200 Union Center Boulevard, Fairfield, Ohio The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations cause the dietary supplement products manufactured and packaged at your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements. You may find the Act and FDA regulations through links at FDA s home page at Our inspection of your facility revealed the following violations of the dietary supplement CGMP regulation (21 CFR Part 111): 1. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR (b). Specifically, you failed to establish component specifications for each component that you use in the manufacture of a dietary supplement. 2. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 1

2 111.75(a)(1)(i). Specifically, your firm did not test or verify the identity of any dietary ingredients used in your products. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR (a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption. 3. Your firm failed to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR Specifically, your firm does not have written procedures for quality control operations. 4. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR (a). Specifically, you confirmed to our investigators that you do not prepare MMRs for any of your products. 5. Your firm failed to follow the requirements for batch production records (BPRs), as required by 21 CFR and Specifically, your BPRs did not include the following required information: A. The identity of equipment and processing lines used in producing the batch, as required by 21 CFR (b) B. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing batch, or a cross reference to records, such as individual equipment logs, where this information is retained, as required by 21 CFR (c) C. The unique identifier that you assigned to each component, packaging, and label used, as required by 21 CFR (d) D. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR (e) and (g), as required by 21 CFR (i) E. Documentation at the time of performance, of the manufacture of the batch with the initials of the persons performing each step, including: a. The initials of the person responsible for weighing or measuring each component used in the batch; b. The initials of the person responsible for verifying the weight or measure of each component used in the batch; c. The initials of the person responsible for adding the component to the batch; d. The initials of the person responsible for verifying the addition of components to the batch. This documentation is required under 21 CFR (j)(2). 2

3 F. Documentation at the time of performance, of packaging and labeling operations, including: 1. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels. 2. An actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the MMR. This documentation is required under 21 CFR (k)(1)-(2). G. Documentation, at the time of performance, that quality control personnel: 1. Approved or rejected any reprocessing or repackaging; 2. Approved and released, or rejected, the batch for distribution including any reprocessed batch; 3. Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement. This documentation is required by 21 CFR (1). 6. Your firm failed to make and keep records to fulfill the requirements related to components, packaging, and labels, and for products received for packaging and labeling as a dietary supplement, as required by 21 CFR (a). Specifically, you have not made or kept receiving records for components, as required by 21 CFR (b)(2). 7. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR Specifically, you have not established written procedures for the review and investigation of product complaints. In addition, your firm failed to make and keep the records of these procedures, as required by 21 CFR (b)(1). 8. Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR Specifically, you have not established written procedures that specify the procedures to be followed when a dietary supplement is returned by a customer. In addition, your firm failed to make and keep records of these procedures, as required by 21 CFR (b)(1). 9. Your firm failed to establish and follow written procedures for required steps in the manufacturing process. Specifically, you failed to establish written procedures for manufacturing operations, as required by 21 CFR In addition, your firm failed to make and keep records of these procedures, as required by 21 CFR (b). 3

4 10. Your firm failed to establish and follow written procedures to fulfill the requirements related to packaging and labeling operations, as required by 21 CFR Specifically, you have not established written procedures for packaging and labeling operations. In CFR (b). 11. Your firm failed to establish and follow written procedures to fulfill the requirements related to holding and distributing operations, as required by 21 CFR Specifically, you have not established written procedures for holding and distributing operations. In CFR (b)(1). 12. Your firm failed to follow numerous requirements related to personnel. Specifically, your firm failed to use hygienic practices to the extent necessary to protect against contamination, as required by 21 CFR (b)(2). Your firm also failed to ensure that personnel remove all jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand [21 CFR (b)(4)], and failed to ensure that personnel wear beard covers where appropriate [21 CFR (b)(5)]. Our investigators noted the following practices: A. An employee manufacturing Graham Cracker Energy Bars reached elbow deep into the mixing bowl, but only washed and sanitized their hands and wrists. B. A different employee reached into the same mixing bowl while wearing a diamond ring. C. Two male employees with facial hair were observed manufacturing without wearing beard nets. 13. Your firm failed to establish and follow written procedures to fulfill the requirements related to equipment and utensils, as required by 21 CFR Specifically, you failed to establish written procedures for calibrating instruments and controls, inspecting equipment, and cleaning and sanitizing equipment that you use in manufacturing a component or dietary supplement [21 CFR (a), 21 CFR (c)]. In addition, your firm failed to make and keep records of these procedures, as required by 21 CFR (b)(1). 14. Your firm failed to establish and follow written procedures to fulfill the requirements related to your physical plant and grounds, as required by 21 CFR Specifically, you failed to establish written procedures for cleaning the physical plant and for pest control. In CFR (b). We received your response to the FDA 483 on March 21, Although you state in your response that you are working to address all of FDA s concerns, you failed to provide detailed information and documentation that would assist us in evaluating whether you have implemented the necessary corrections. Therefore, your response is inadequate. 4

5 The above violations are not intended to be an all-inclusive list of the violations at your dietary supplement facility. You are responsible for ensuring that your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to take appropriate corrective action may result in regulatory action, including seizure and/or injunction, without further notice. In addition to the above violations, we have the following comment: Your firm does not retain reserve samples for one year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations, as required by 21 CFR (b). Specifically, you informed our investigator that you only hold reserve samples for six months from the date of manufacturing. You should respond in writing within 15 working days from your receipt of this letter. Your response should include each step taken or that will be taken to correct these violations and to prevent their recurrence. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, state the reason for the delay and when you will correct the remaining violations. Your response should be sent to: Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, OH If you have questions regarding any issues cited in this letter, please contact Ms. Hunter at , Extension 2134 or at allison.hunter@fda.hhs.gov. Sincerely /s/ Paul J. Teitell District Director Cincinnati District Office 5