OTC Drug Production Ceased after FDA Warning Letter

On 07 April 2025, the FDA issued a Warning Letter to PMS4PMS, LLC following significant CGMP violations observed during an inspection in November 2024 at their Clarence, NY facility.

Key issues identified:

• No testing for identity and strength of active ingredients before product release.
• No stability data supporting a 5-year expiration date.
• A non-functional quality unit with inadequate control over GMP activities, including training, documentation, complaint handling, and supplier qualification.
• The firm's OTC product was illegally marketed and misbranded due to therapeutic claims beyond the OTC monograph (M017).

The company’s response to the Form 483 was inadequate, prompting the FDA to recommend engaging a qualified GMP consultant. The company agreed to cease production at the facility and must notify the FDA before resuming manufacturing.

For more details, see the full Warning Letter on the FDA website.

03-05-2025