FDA 483 - Private Label Partners, Inc. - January 17, 2025

Private Label Partners, Inc., a drug manufacturer in Santa Ana, CA, was inspected by the FDA from January 13-17, 2025. The inspection revealed significant deficiencies across multiple quality systems, including inadequate finished product and component testing, failure to follow stability programs, insufficient investigations into out-of-specification results, and missing batch records. These findings indicate a lack of robust controls to ensure the identity, strength, quality, and purity of drug products.