FDA Warning Letter: Lack of Identity Testing and Stability Program

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter dated 06 November 2023 to a manufacturer of over-the-counter (OTC) drug products.

Based on a review of records the company submitted upon FDA's request, the authority found several significant violations of Current Good Manufacturing Practice (CGMP) regulations.

Identity Testing of Incoming Components

The FDA writes that the firm could not demonstrate that it is testing the identity of incoming components used in the manufacture of the drug products. In addition, incoming lots of ethanol were not tested for methanol.

Although the company claimed to perform the identity testing on all raw materials, only the supplier’s test reports were provided.

Release Testing of OTC Finished Drug Products

Similar to the testing of incoming components, the company could not demonstrate that adequate testing of the OTC finished drug products prior to release for distribution to the United States were performed. Specifically, the Certificates of Analysis (CoAs) the company provided did not include identity test results. The company also stated that due to the high alcohol content in the drug products, no microbiological tests were performed, which is not accepted by the FDA.

The FDA now expects the company to provide

  • "a list of chemical and microbial specifications, including test methods, used to analyze each batch [...],
  • an action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry,
  • a summary of all results obtained from testing retain samples from each batch. [...]"

Stability Testing Program

Finally, again based on the records and information the firm provided, the FDA writes that an adequate stability testing program was not established. The FDA gives the following example: "Specifically, [the company] stated that the shelf life of unopened drug product is two years at room temperature and opened drug product should be used within six months. However, [the company] only provided a 2-week test result under accelerated conditions and an 18-month test result under long term conditions."

The FDA placed the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") on 27 October 2023. The authority strongly recommends engaging a CGMP consultant to support the company in aligning their systems with cGMP requirements.

To view the complete list of violations and the conclusion given by the FDA, please see the Warning Letter to Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi.

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