OTC Drug Production Ceased following FDA Warning Letter

The FDA issued a Warning Letter on April 7, 2025, to PMS4PMS, LLC of Clarence, NY, following a November 2024 inspection that found significant violations of Current Good Manufacturing Practice (CGMP) regulations for its OTC product.

Key issues include:

1. No testing for the identity and strength of active ingredients before release.
2. No stability data supporting the assigned 5-year expiration date.
3. A non-functional quality unit, lacking control over key GMP activities (training, documentation, complaint handling, and supplier qualification).
4. The product was illegally marketed without FDA approval and was misbranded with unapproved therapeutic claims.

The company’s response to the FDA Form 483 was inadequate. The FDA recommends engaging a qualified GMP consultant. The company has committed to ceasing production at the facility and must notify the FDA before resuming operations.

For further details, refer to the FDA’s Warning Letter on their website.

24-04-2025