FDA Warning Letter: Data Integrity and Good Documentation Practice Failures

In November 2022, the U.S. FDA issued a Warning Letter to the U.S. American company Kari Gran Inc. after having inspected its site in July 2022.

The significant violations of cGMP regulations for finished products, which are mentioned in the Warning Letter, are listed as follows:

  • "Your firm 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. Your firm also failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.165(a) and 21 CFR 211.166(a))."
  • "Your firm failed to conduct at least (b)(4) to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2))."
  • "Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also 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 211.100 (a) and 21 CFR 211.188)."
  • "Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22)."

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a consultant to support the company in aligning their systems with cGMP requirements. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as drug manufacturer until the site has addressed all observations and fully complies with cGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter to Kari Gran Inc.

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