FDA 483 - AXXELENT PHARMA SCIENCE PRIVATE LIMITED - June 21, 2024

Axxelent Pharma Science Private Limited in Sri City, India, was inspected by the FDA from June 17-21, 2024, and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results, lack of proper equipment cleaning procedures, insufficient employee CGMP training, and poor laboratory record-keeping and data review practices. These issues indicate a systemic failure to adhere to current good manufacturing practices.