FDA 483 - Ajanta Pharma Limited - June 22, 2019

Ajanta Pharma Limited, a drug products manufacturer in Bharuch, Gujarat, India, was cited for significant deficiencies in its quality system and laboratory controls during an FDA inspection. Observations included a failure to thoroughly investigate market complaints regarding product odor and potential contamination, as well as inadequate oversight of contract laboratory data and a lack of testing for leachable and extractables in primary packaging components. These issues indicate a potential risk to product quality and patient safety.