小中大MISBRANDING VIOLATIONS
In addition to violating CGMP, your firm shipped a misbranded active pharmaceutical ingredient to the U.S. As described above, according to our inspection, your firm prepared a certificate of analysis (COA) for gabapentin on your firm’s letterhead, indicating that the product was manufactured by your firm, Zhejiang Jiuzhou Pharmaceutical Co., Ltd, when in fact it was not. The gabapentin was manufactured by (b)(4). In addition, the expiration date on your firm’s COA is not one supported by the COA from the original manufacturer, (b)(4).
Moreover, your firm relabeled gabapentin and included on the label an official stamp that identifies your firm, Zhejiang Jiuzhou Pharmaceutical Co., Ltd, as the manufacturer of the product, rather than the actual manufacturer, (b)(4). Based on our findings, the active pharmaceutical ingredient, gabapentin, is misbranded within the meaning of Section 502(a) of the Act [21 U.S.C. 352(a)] in that its labeling is false or misleading in any particular. See also 21 CFR 201.1(h)(2).
The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations.
If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Program immediately, as you begin your internal discussions, at drugshortages@fda.hhs.gov so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Program also allows you to meet any obligations you may have to report discontinuances in the manufacture of your drug under 21 U.S.C. 356C(a)(1), and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may be able to take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.
Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Zhejiang Jiuzhou Pharmaceutical Co., in Zhejiang, China, into the United States under Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). The articles may be subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the APIs at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI numbers 3003744377 and 3010365339.
Please send your reply to: Mary E. Farbman, Ph.D., Compliance Officer; 10903 New Hampshire Avenue Building 51 Room 4234; Silver Spring, MD 20993.
Sincerely,
/S/
Thomas Cosgrove
Acting Director
Office of Manufacturing and Product Quality
Center for Drug Evaluation and Research
/S/
Eric Nelson
Director
Division of Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
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