FDA 483 - Galentic Pharma (India) Pvt. Ltd - December 08, 2022

An FDA inspection of Galentic Pharma (India) Pvt. Ltd, a manufacturer of sterile and non-sterile drug products, revealed significant deficiencies across its operations. The firm failed to establish and follow adequate procedures for preventing microbiological contamination in sterile products, lacked proper validation for aseptic processes, and exhibited weaknesses in its quality control unit's authority and record reconciliation. Additionally, issues were noted in laboratory controls, equipment cleaning, change control, drug product testing, employee training, stability programs, and data integrity.