FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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

  • "Failure to demonstrate that your manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes."
  • "Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications."
  • "Failure to ensure that API lots meet specifications prior to blending with other lots."

In the Warning Letter it is stated that the company's quality systems are inadequate and that the site is missing an "ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality". That's why it is explicitly mentioned that the U.S. FDA expects that the company is aligning their systems with the requirements of the ICH Q7 guideline.

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 may withhold approval of 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 ALI Pharmaceutical Manufacturing, LLC.

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