FDA WARNING_LETTER - Product Society LLC - November 27, 2024

On May 8, 2025, the FDA issued a Warning Letter to Product Society LLC following an inspection from November 18-27, 2024, at their North Hollywood, CA drug manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming components like glycerin for identity, including for hazardous impurities like Diethylene Glycol (DEG) and Ethylene Glycol (EG), and failed to validate supplier test analyses. Their water system, used as a component, was also not adequately monitored to meet USP specifications. 2. **Inadequate production and process controls:** The firm failed to establish adequate written procedures and validate manufacturing processes for OTC drug products, failing to ensure consistent product quality. 3. **Deficient quality control unit:** The quality unit lacked adequate control over manufacturing operations and failed to ensure proper procedures were in place, indicating inadequate quality systems.

The letter acknowledges the firm's commitment to cease OTC drug production and deregister as a drug manufacturer. Product Society LLC must clarify if they intend to resume drug manufacturing for the U.S. market. If so, they must notify the FDA and consider engaging a qualified consultant. The firm has 1