Apitoria Pharma Private Limited – FDA 483, Aug 24, 2026

Apitoria Pharma Private Limited, an API manufacturer in Anakapalli District, India, was cited for significant quality unit deficiencies during an FDA inspection. Observations included inadequate investigations into numerous laboratory occurrences, a "repeat until pass" pattern for system suitability test failures without proper root cause analysis, and a failure to thoroughly investigate a leachable impurity and its impact on released API batches. These issues indicate a weak quality system risking unreliable product quality data.