OTC Drug Production Ceased after FDA Warning Letter

The U.S. Food and Drug Administration (FDA) issued a new Warning Letter dated 07 April 2025 for significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, particularly concerning the firm's OTC product. This was observed during an inspection of the drug manufacturing facility in Clarence, NY, in November 2024.

Key findings include:

• No testing for identity and strength of active ingredients before product release.
• No stability data to support the assigned 5-year expiration date.
• A non-functional quality unit lacking control over critical GMP activities, including training, documentation, complaint handling, and supplier qualification.

The firm’s OTC product was also found to be illegally marketed without FDA approval and misbranded due to therapeutic claims beyond those permitted under the relevant OTC monograph (M017).

The response provided by the company to the FDA's Form 483 was deemed inadequate, lacking sufficient documentation and corrective actions. As a result, the agency strongly recommends the engagement of a qualified GMP consultant.

The company has stated it will cease production of the product at the inspected facility. The firm must inform the authority before resuming any manufacturing operations regulated under the FD&C Act.

For further information, please see the complete Warning Letter to PMS4PMS, LLC, published on the FDA's website.