FDA Sent These 10 Warning Letters for Pharma Companies | January 2017

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether.

From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent):

  • Berkeley Nutritional Manufacturing Corporation, Livermore, CA – 6 violations:
    • Failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70:
      • Failed to establish an identity specification for each component used in the manufacture of a dietary supplement as required by 21 CFR 111.70(b)(1).
      • Failed to establish component specifications that are necessary to ensure that the specifications for purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
    • Failed to identify the product using the term ”dietary supplement” in accordance with 21 CFR 101.3(g).
    • Failed to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
    • Product does not conform to the definition and standard for chocolate as noted in 21 CFR 163.110.
  • Ausmetics Daily Chemicals, Guangzhou, China – 4 violations:
    • Failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)).
    • Failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
    • Failed to ensure the identity of components sourced from various suppliers, including active ingredients (21 CFR 211.84(d)(1) and (2)).
    • Failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188)).
  • Zhejiang Bangli Medical Products Co., Yongkang City, China – 5 violations:
    • Firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
    • Failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).
    • Failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
    • Failed to establish written procedures to prevent mix-ups and cross contamination by physical or spatial separation from operations on other drug products (21 CFR 211.130(a)).
    • Firm delayed, denied, or limited an inspection, or refused to permit the FDA inspection.
  • CTX Life Sciences Pvt., Surat, India – 4 violations:
    • Failure to have adequate cleaning procedures to prevent contamination or carry-over material that would alter API quality.
    • Failure of quality unit to exercise its responsibility to ensure the API manufactured at facility are in compliance with CGMP, and meet established specifications for quality and purity.
    • Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and conclusions are recorded.
    • Failure to ensure that test procedures are scientifically sound and appropriate to ensure that API conform to established standards of quality and/or purity.
  • Porton Biopharma, Salisbury, United Kingdom – 3 violations:
    • 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).
    • Failed to establish and follow appropriate written procedures, designed to prevent microbiological contamination in drug products purporting to be sterile (21 CFR 211.113(b).
    • Failure to establish and follow change controls to evaluate all changes that could affect the production and control of intermediates or API.
  • FACTA Farmaceutici, Milan, Italy – 2 violations:
    • Failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
    • Failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
  • Walter’s Pharmacy, Allentown, PA – 4 violations:
    • Failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).
    • Failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination (21 CFR 211.28(a)).
    • Failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
    • Failed to test samples of each component of a drug product for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).
  • Ningbo Zhixin Bird Clean-Care Product Company, Cixi City, China – 4 violations:
    • Firm’s quality control unit failed to review and approve all drug product production and control records, including those for packaging and labeling, to determine compliance with all established, approved written procedures before a batch is released or distributed (21 CFR 211.192).
    • Firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
    • Failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
    • Failed to establish and follow adequate written procedures designed to assure batch uniformity and integrity of drug products that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch (21 CFR 211.110(a)).
  • Suzhou Pharmaceutical Technology Co., Ltd, Suzhou, China – 3 violations:
    • Failure to transfer all quality or regulatory information received from the API manufacturer to customers.
    • Failure to have a quality unit responsible for reviewing and approving all appropriate quality-related documents, including Certificates of Analysis.
    • Failure to have facilities suitable for the storage of all materials under appropriate conditions.
  • Sato Yakuhin Kogyo Co., Ltd., Kashihara City, Japan – 2 violations:
    • Failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)(4)).
    • 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).

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