We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.”
From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent):
- Vikshara Trading & Investments Ltd, Ahmedabad, India – 3 violations:
- Firm delayed FDA’s attempts to schedule a pre-announced inspection.
- Firm limited FDA’s inspection.
- Failure to provide records required to be readily available for authorized inspection (21 CFR 211.180(c)).
- Huron Pharmaceuticals, Inc., Farmington Hills, MI – 3 violations:
- Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
- Failure to establish, document, and implement an effective system for managing quality.
- Failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.
- Exact-Rx, Inc., Melville, NY – 1 violation:
- The firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under Section 301(p) [21 U.S.C. 360(j) and 331(p)]. In addition, firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act. Introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) [21 U.S.C. 352(o) and 331(a)].
- AIE Pharmaceuticals, Inc., Ontario, CA – 1 violation:
- Products are intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Products do not bear adequate directions for their intended use and, therefore, are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].
- Divi’s Laboratories Ltd. (Unit II), Andhra Pradesh, India – 3 violations:
- Failure to ensure that test procedures are scientifically sound and appropriate to ensure that site API conform to established standards of quality and/or purity.
- Failure to prevent unauthorized access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data.
- Limiting access to or copying of records.
- Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd., Zhejiang, China – 2 violations:
- Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of API.
- Failure to establish a sampling plan based on scientifically-sound sampling practices.
- Mylan Pharmaceuticals, Inc., Canonsburg, PA – 2 violations:
- The firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
- The firm failed to establish an adequate quality control unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
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