Warning Letters

FDA Sent These 7 Warning Letters for Pharma Companies | February 2017

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 (again) to failing to produce suitable water.

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

  • Megafine Pharma, Mumbai, India – 4 violations:
    • Failure of quality unit to exercise its responsibility to ensure the drugs manufactured are in compliance with CGMP, and meet established specifications for quality and purity.
    • Failure to establish and follow adequate written procedures for cleaning equipment and its release for use in API manufacture, and to maintain adequate records of major equipment usage.
    • Failure to ensure all specifications and test procedures are scientifically sound and appropriate to ensure that drugs conform to established standards of quality and/or purity.
    • Failure to control the issuance, revision, superseding, and withdrawal of all documents by maintaining revision histories.
  • Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City, China – 3 violations:
    • 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 adequately investigate out-of-specification results.
    • Failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.
  • Morton Grove Pharmaceuticals, Inc., Morton Grove, IL – 6 violations:
    • 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).
    • Firm 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)).
    • Firm failed to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).
    • Firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
    • Firm’s quality control unit failed to test in-process materials during the production process (21 CFR 211.110(c)).
    • Firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
  • Hospira Inc, New York, NY – 5 violations:
    • 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).
    • Firm failed to establish valid in-process specifications (21 CFR 211.110(b)).
    • Firm 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)).
    • Firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)).
    • Firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
  • Chongqing Pharma Research Institute Co., Chongqing, China – 1 violation:
    • Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
  • Resonance Laboratories Pvt., Bangalore, India – 2 violations:
    • Failure to validate water system is capable of consistently producing water suitable for its intended use.
    • Failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.
  • Sato Pharmaceutical Co., Tokyo, Japan – 2 violations:
    • Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
    • Firm 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)).

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