FDA 483 - Product Society LLC - November 27, 2024

An FDA inspection conducted from November 18 to November 27, 2024, at Product Society LLC in North Hollywood, CA, revealed significant manufacturing deficiencies. The inspection identified a range of concerns regarding the firm’s compliance with Current Good Manufacturing Practices (CGMP) for drug products.

Key observations include inadequate laboratory controls, specifically lacking scientifically sound specifications and test procedures for components and in-process materials, including water system testing for objectionable organisms and validation. The company also failed to establish written production and process controls, such as process validation for drug products and adequate hold time studies for bulk intermediates. Furthermore, Product Society LLC lacked a written stability testing program to justify assigned two-year expiration dates for Over-the-Counter (OTC) drug products and failed to print expiration dates on external labeling for certain products.

Additional issues encompass insufficient record-keeping, with no annual product reviews conducted and incomplete batch records. The firm did not consistently follow established test procedures for product quality, relied solely on supplier certificates of analysis without performing adequate identification tests for raw materials, and failed to adhere to its own procedures for incoming material inspections and vendor qualification. Finally, the Quality Control unit did not fully follow its responsibilities, evidenced by undocumented changes to master batch records and a failure to initiate investigations for out-of-specification results. Product Society LLC is required to address these serious observations to ensure the quality, safety, and efficacy of its manufactured drug products.