FDA 483 - Apitoria Pharma Private Limited - September 27, 2024

An FDA inspection of Apitoria Pharma Private Limited in Sanga Reddy District, Telangana, India, revealed ten significant deficiencies in their API manufacturing operations. The observations highlight inadequate equipment maintenance and qualification, insufficient manufacturing instructions and personnel training, and failures in quality unit oversight, water system design, and deviation investigations. These issues collectively indicate a broad lack of adherence to cGMP principles, posing a moderate to severe risk to the quality and integrity of drug substances.