FDA Warning Letter: Inadequate API testing

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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

  • "Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2))."
  • "Your firm failed to establish 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 (21 CFR 211.100(a))."
  • "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 for identity of their APIs. Additionally, the suppling companies weren't sufficiently qualified enough to rely on their CoAs (certificates of analysis), which was also done by the inspected company (see observation 1). Testing and sampling of incoming goods are mandatory to verify the identity of the received materials and cGMP qualified suppliers are required, especially if the company wants to use their CoAs to skip further incoming tests. 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 strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements and to do a so called "comprehensive six-system audit". Additionally, the U.S. FDA may refuse new applications 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 Omega Packaging Corp.

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