FDA 483 - Aurobindo Pharma Limited - May 10, 2022

Aurobindo Pharma Limited, a drug manufacturer in Polepally, India, was cited for significant deficiencies across its quality system. The inspection revealed inadequate investigations into out-of-specification results, a lack of validated production and process controls, and failures in following stability testing programs. Additionally, issues with data integrity, incomplete batch records, and inappropriate equipment design were noted, indicating a systemic breakdown in ensuring drug product quality and purity.