FDA Warning Letter: Observed particulates in repackaged drug components

In January 2024, the U.S. FDA issued a Warning Letter to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023.

The significant violations of CGMP regulations for active pharmaceutical ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:

  • "Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis."
  • "Failure to document, explain, and investigate any deviation from established procedures."

According to the Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs. Various unidentified colored particulates were reported in the production records - especially mentioned are insects, hair and fibers. It is also claimed in the U.S. FDA Warning Letter that the respective batches were not rejected and that a complete identification of the contamination including the root cause is missing. Additionally, the company did not comply with their own internal procedures and miss to do a correct CAPA and fully documentation of the contamination. So that the manufacturing site failed to assess the safety risk of the contaminated drugs released and notifying the respective customers accordingly.

To identify, define and to minimize the presence of particles in APIs the good practices described in the APIC guidance document "Guidance on Handling of Insoluble Matter and Foreign Particles in APIs" could be more than useful and is available on the APIC webpage.

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. Additionally, the U.S. FDA placed the company on Import Alert in January 2024 and 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 Glicerinas Industriales, S.A. de C.V.

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