Pristine Bay LLC dba Vianda 4/26/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237
VIA United Parcel Service
April 26, 2013
Charles J. Kubicki, Owner
Pristine Bay, L.L.C. d.b.a. Vianda
7175 E. Kemper Rd.
Cincinnati, OH 45249
WARNING LETTER CIN-DO 13-361158-19
Dear Mr. Kubicki:
The U.S. Food and Drug Administration (FDA) conducted inspections at your facilities, located at 1661 Waycross Rd., Cincinnati, OH, on August 28 – September 17, 2012, and 7165 E. Kemper Rd., Cincinnati, OH, on August 28, 2012. The inspections revealed that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your “Enzyte”, “Ogoplex”, and “Avlimil Complete” dietary supplements 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 requirements for dietary supplements. You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
- Your firm failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure that the quality of the dietary supplement, as required by 21 CFR 111.70(a). Specifically, your firm failed to establish finished product specifications for the identity, purity, strength, and composition of your finished dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, your finished dietary supplements to ensure quality, as required by 21 CFR 111.70(e). Our inspections found that your firm has entered into agreements with other manufacturers to manufacture your dietary supplements and that your firm conducts holding and distribution operations for these products. In addition, your firm develops and sends product formulations describing the formula and composition for your “Enzyte”, “Ogoplex”, and “Avlimil Complete” dietary supplements to these manufacturers. However, you do not have any finished product specifications for these dietary supplements, as required by 21 CFR 111.70 (a) and (e).
Your chief operating officer told our investigator that your firm hired a pharmacologist to develop product specifications and that you will be working closely with your contract manufacturers. Please note that once you establish specifications, you must make and keep records of established specifications (21 CFR 111.95(b)(1)). Furthermore, your firm was cited for not establishing product specifications during a previous inspection conducted on July 13- 20, 2010.
- Your firm failed to implement quality control operations to ensure the quality of your dietary supplements, as required by 21 CFR 111.65. Your firm does not perform any quality control operations; nor does it have designated quality control personnel to perform the quality control operations required under 21 CFR Part 111, Subpart F. You firm also failed to identify a person who is currently responsible for your quality control operations, as required by 21 CFR 111.12(b). In addition, your firm failed to establish written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). While you provided some written procedures for quality control operations, your warehouse manager stated that your firm has not been following such procedures since your quality control manager left your firm in July 2011. Further, these written procedures do not include procedures for quality control personnel conducting a material review and making a disposition decision. Your firm’s quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h).
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
Although, your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (explaining that an offense can be committed under the Act by anyone who has a “responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g), 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
Your firm must establish a system of production and process controls and implement quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record (21 CFR 111.55 and 111.65). You firm must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval of release for any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). However, you do not conduct quality control review to ensure the quality of the dietary supplements that you distribute and that they are packaged and labeled according to the master manufacturing record.
In addition, your firm was cited for not implementing quality control operations during a previous inspection conducted on July 13-20, 2010.
3. Your firm failed to follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. You must hold dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the dietary supplements are not affected, as required by 21 CFR 111.455(a). While your written procedures for holding and distribution operations provide that your firm will hold finished product in a storage area under appropriate conditions, your firm was not able to show that such procedures were being followed, such as by providing documents (e.g., inspection logs) or other information. In fact, your warehouse manager, who is responsible for warehouse procedures and responsibilities, stated that she was not aware of the procedures.
4. Your quality control personnel failed to review and approve decisions about whether to investigate a product complaint, as required by 21 CFR 111.560(b). Specifically, on September 12, 2011, a customer called and reported that your product, “Enzyte”, had caused a heart attack and made kidneys retain fluid. This complaint was not reviewed by quality control personnel and was not investigated for further follow-up action.
Furthermore, you failed to keep written records of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2). Specifically, all complaints from July 13, 2010 to August 28, 2012, were requested for review during our inspection. However, your firm could only find complaint records taken by one employee from July 22, 2011 to September 16, 2011.
5. Your firm failed to report a Serious Adverse Event Report (SAER) for a dietary supplement within the statutory 15 business days, as required under Section 761 of the Act [21 USC 379aa-1]. Specifically, as described above, your firm received a complaint on September 12, 2011, for your “Enzyte” product from a customer asserting that the dietary supplement had caused the customer to have a heart attack and make the customer’s kidneys retain fluid. However, your firm failed to submit a SAER to FDA for this adverse event, as required by section 761 of the Act.
Under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements to FDA no later fifteen (15) business days after a report of the event is received through the address or phone number provided on your dietary supplement products. Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within 15 business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found online in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” available on our website at www.fda.gov
We reviewed your response letter dated October 5, 2012, which explains that many of your stated corrections include drafting and updating SOPs and training your employees. However, your response is not adequate because the revised SOPs and details about the training were not provided for our review to determine if your corrections will ensure that your dietary supplements are manufactured, packaged, labeled, and held according to current Good Manufacturing Practices. Further, our inspections determined that your employees have not followed your current SOPs. In fact, your chief operating officer, in charge of daily operations, stated that your firm’s Good Manufacturing Practices procedures have not been followed since July 2011.
This letter is not an all-inclusive list of the violations at your facility. You are responsible for ensuring that your firm complies with the Act and its implementing regulations, including the dietary supplement CGMP regulations (21 CFR Part 111). You should take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsibility party for the domestic facility. The inspection noted in this letter identified noncompliance materiality related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should include the specific steps that you are taking correct these violations. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should be sent to U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, Attention: Karen Gale Sego, Compliance officer. If you have questions regarding the content of this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164.
Paul J. Teitell