Epic Pharma, LLC – FDA 483, Jun 12, 2026

An FDA inspection of Epic Pharma, LLC in Laurelton, NY, from June 8-12, 2026, revealed significant deficiencies across multiple areas of their manufacturing operations. The firm was cited for inadequate quality control unit procedures, including failures in equipment and supplier requalification, poor document control, and critical lapses in quality oversight that resulted in the release of mislabeled and improperly tested drug products. Additionally, the inspection found issues with equipment cleaning and maintenance, and a severe lack of appropriate controls over computer systems and manufacturing equipment, raising concerns about data integrity and product quality.