FDA 483 - Piramal Pharma Limited - February 13, 2025

Piramal Pharma Limited in Sangareddy District, India, was cited for significant deficiencies in its quality control, production, and documentation practices during an FDA inspection. Observations included a lack of written procedures for alarm review and equipment maintenance, inadequate OOS investigations, and insufficient documentation of critical process parameters and yields in batch records. These issues indicate a systemic breakdown in ensuring product quality and compliance.