FDA Warning Letter: Missing Identification Tests

In March 2024, the U.S. FDA issued a Warning Letter to the company "Master Paints & Chemicals Corp." after having inspected its site in October 2023.

The significant violations of CGMP regulations for drug 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 (21 CFR 211.165(a))."
  • "Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1))."
  • "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)."

According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests to identity their raw materials. Additionally, it is stated that the company used third-party laboratories for identification testing. The qualification of these labs was not sufficiently described as well (see observation 2). Testing and sampling of incoming goods is mandatory to verify the identity of the received materials and CGMP qualified suppliers are required. The "ICH Q7 Good manufacturing practice for active pharmaceutical ingredients" guideline clearly describes these requirements in chapter 7.3 "Sampling and Testing of Incoming Production Materials".

The observed findings resulted in a long list of remediation activities and CAPA measurements requested.
Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA may refuse new applications listing the company as drug manufacturer and export certificates until the site has addressed all observations and fully complies with CGMP requirements, which might be checked by a further inspection. Engaging a consultant to ensure that the company will be CGMP compliant from now on is highly recommended in the Warning Letter.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Master Paints & Chemicals Corp.

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