FDA 483 - Exela Pharma Sciences LLC - November 15, 2024

Exela Pharma Sciences LLC received a Form 483 citing numerous deficiencies across its drug manufacturing and 503B outsourcing facilities. Key issues include inadequate investigations into discrepancies and OOS results, failures in maintaining sterile conditions, and deficiencies in laboratory controls, data integrity, and equipment calibration. The firm also lacked proper stability data, personnel training for visual inspection, and compliant labeling for its outsourcing facility drug products.