Warning Letters

FDA Sent These 7 Warning Letters for Pharma Companies | November 2016

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination.

From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent):

  • Wockhardt Limited, Mumbai, India – 2 violations:
    • Failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. (21 CFR 211.113(b))
    • Failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. (21 CFR 211.42(c)(10))
  • Dongying Tiandong Pharmaceutical Co., Dongying, China – 4 violations:
    • Failure to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions.
    • Failure to ensure that test procedures are scientifically sound and appropriate to ensure that the site’s API conform to established standards of quality and/or purity.
    • Failure to adequately monitor crude heparin suppliers.
    • Failure of the quality unit to ensure that all critical deviations are investigated and resolved.
  • Stonegate Pharmacy, Austin, TX – 7 violations:
    • Failed to ensure the system for cleaning and disinfecting equipment is adequate to produce aseptic conditions. (21 CFR 211.42(c)(10)(v))
    • Failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. (21 CFR 211.113(b))
    • Failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. (21 CFR 211.42(c)(10)(iv))
    • 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 ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination. (21 CFR 211.28(a))
    • 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)
    • Firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. (21 CFR 211.167(a))
  • Srikem Laboratories, Navi Mumbai, India – 2 violations:
    • Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
    • Failure to follow and document laboratory controls at the time of performance.
  • Sekisui Medical Co., Tokyo, Japan – 3 violations:
    • Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established API specifications and standards.
    • Failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.
    • Failure to ensure that analytical methods used to test API are appropriately validated and verified.
  • Pine Pharmaceuticals, Tonawanda, NY – 2 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).
    • 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)).
  • Valeant Pharmaceuticals International, Bridgewater, NJ – 5 violations:
    • Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
    • Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verifications, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
    • Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
    • Failure to establish and maintain procedures for to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
    • Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part, as required by 21 CFR 820.20(b).

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