FDA Warning Letter to Californian Drug Manufacturer

End of March 2023, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 13 March 2023. The letter follows an inspection from 14 to 22 September 2022 at the company's drug manufacturing facility in California. Once again, as with numerous Warning Letters in recent weeks, it is about a manufacturer of hand sanitizer drug products.

Overall, the FDA considers the firm’s quality systems as inadequate and strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements.

Four thematic areas are addressed in detail:

Release Testing

The first CGMP violation described in the Warning Letter concerns the release testing of the hand sanitizer drug product. According to the FDA, a full release testing was not conducted. In particular, there was a lack of strength and identity testing of the active ingredient (ethanol), and appropriate impurity and microbiological testing.

Sampling

The FDA writes that the company „failed to test incoming active pharmaceutical ingredients (API) (e.g., ethanol) and other components (e.g., deionized (DI) water) used to manufacture over-the-counter drug products to determine their identity, purity, strength, and other appropriate quality attributes.“ Instead, it relied on the COAs from unqualified suppliers.

In addition, it was not ensured that the „water system can consistently produce water suitable for drug manufacturing, and, at a minimum, meets the USP monograph for Purified Water and appropriate microbial limits.“

Stability Testing

Another deficiency concerns the stability program. The authority writes that the firm lacked stability data to support the expiration dates of the distributed hand sanitizer drug product. Thus, there is no evidence that the „drug product will meet established specifications and all pre-determined quality criteria throughout their shelf life.“

Process Validation

The fourth deficiency described in the Warning Letter is about the lack of process validation. Apparently, no documents could be presented in this regard. The FDA now expects the company to conduct the studies required by the GMP regulations (e.g., completed process performance qualification) and to provide the FDA with various documents (written procedures for qualification of equipment and facilities, assessment of each drug product process, etc.).

For more information, please see the full Warning Letter to NuGeneration Technologies LLC published on the FDA website.