FDA 483 - Epic Pharma, LLC - February 01, 2019

An FDA inspection of Epic Pharma, LLC in Laurelton, NY, revealed multiple significant deficiencies across its manufacturing operations. The firm failed to adequately validate manufacturing processes and cleaning procedures, ensure drug product conformity through proper testing, and maintain its water systems and environmental controls. Additionally, issues were noted with equipment calibration and the storage conditions for drug products, indicating a broad lack of adherence to quality standards.