Samson Pharmaceuticals, Inc – FDA 483, Apr 29, 2026

An FDA inspection of Samson Pharmaceuticals, Inc. in Commerce, CA, revealed significant deficiencies across its quality control, aseptic processing, and laboratory systems. The firm lacked written procedures for quality control, failed to prevent microbiological contamination, and did not adequately investigate out-of-specification results. These issues indicate a systemic breakdown in ensuring the quality and sterility of its drug products.