FDA 483 - Piramal Pharma Solutions Inc. - January 10, 2023

An FDA inspection of Piramal Pharma Solutions Inc in Lexington, KY, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adhere to quality control unit procedures, did not record or justify deviations from test methods, and maintained inadequate equipment and laboratory records. These issues indicate systemic problems with quality management and data integrity.