FDA Sent These 6 Warning Letters for Pharma Companies | October 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate.

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

• Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhangjiang City, China – 3 violations:
  • 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)).
  • Failed to 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 adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
• Aztex Enterprises Ltd., Burlington, Canada – 1 violation:
  • 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)).
• Accelerated Analytical Laboratories, Inc., Milwaukee, WI – 1 violation:
  • Failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

• Kim Chemicals Private Ltd., Raigad, India – 3 violations:
  • Failed to 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 an adequate quality control unit and procedures applicable to the 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) and (d)).
  • 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)).
• Ridge Properties, LLC, Salem, OR – 6 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 establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).
  • Failed to establish an adequate quality control unit and procedures applicable to the 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) and (d)).
  • 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).
  • Failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
  • Failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
• Vital Laboratories Private Limited, Vapi, India – 4 violations:
  • Failed to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded.
  • Failed to adequately document the completion of each significant step in the batch production records with signatures of the persons performing and directly supervising or checking each critical step in the operation.
  • Failed to adequately investigate and document out-of-specification results and implement appropriate corrective actions.
  • Failure of quality unit to adequately perform annual product reviews.