FDA 483 - Oxalis Labs - March 14, 2025

Oxalis Labs, a finished drug product manufacturer in Baddi, India, was cited for significant deficiencies during an FDA inspection. The firm failed to maintain critical production and testing records, implement adequate control procedures for manufacturing process changes, and thoroughly investigate unexplained discrepancies and equipment malfunctions. Additionally, manufacturing equipment was not properly evaluated for design, cleaning, and maintenance, indicating systemic issues in quality control and record-keeping.