Product Society LLC – FDA 483, Jun 12, 2026
Product Society LLC, a contract manufacturer in North Hollywood, CA, received a Form 483 for significant deficiencies across its quality system, laboratory controls, and production processes. The firm failed to thoroughly investigate out-of-specification results and discrepancies, did not adequately qualify equipment or establish a robust stability testing program for its OTC drug products, and lacked validated test methods and manufacturing processes. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its drug products.
ID · d77f9c6f-dfac-4cb1-bbfa-633f76ef46f9
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.