FDA 483 - Product Society LLC - November 27, 2024

Product Society LLC, a manufacturer of OTC drug products in North Hollywood, CA, was cited for significant deficiencies across its quality control and manufacturing processes during an FDA inspection. Observations included inadequate laboratory controls, lack of written production procedures, absence of a stability testing program, and failures in record maintenance and quality unit responsibilities. These issues indicate a systemic lack of adherence to good manufacturing practices for drug products.