FDA 483 - Dr. Reddy’s Laboratories Limited - July 07, 2022

An FDA inspection of Dr. Reddy's Laboratories Limited in Pydibhimavaram, India, from June 30 to July 7, 2022, revealed significant deficiencies. The firm failed to establish and follow adequate procedures to prevent microbiological contamination of sterile drug products, including issues with environmental monitoring. Additionally, the quality control unit did not fully adhere to written procedures, specifically regarding the investigation of particle and fiber defects found in media fill batches.