FDA 483 - Dr. Reddy's Laboratories Ltd. - October 27, 2023

This FDA Form 483 was issued to Dr. Reddy's Laboratories Ltd., a drug manufacturer located in Medchal - Malkajgiri, Telangana, India (FEI Number: 3002949099). The inspection occurred from October 19 to October 27, 2023. Dr. Ranjana B Pathak, Global Head of Quality, was the recipient of the report.

Ten observations were noted:

1. **Equipment Cleaning and Maintenance:** Major production equipment (e.g., PRE-078) was not appropriately cleaned and maintained, with residues and spillage observed while in "TO BE CLEANED" status, indicating potential contamination. 2. **Quality Control Unit Procedures:** The quality control unit failed to establish adequate written procedures for production and process controls to assure drug product identity, strength, purity, and quality. 3. **Laboratory Equipment Calibration:** Major laboratory equipment (HPLCs, GCs, UV Spectrophotometers) used for commercial release and stability analysis did not meet calibration specifications. 4. **Building Maintenance:** Core processing areas were not maintained in a good state of repair, with cracks, chipped paint, and exposed concrete observed in Room # in the module manufacturing area/Unit (housing equipment ID: TEA-001), posing risks of mix-up or contamination. 5. **Gowning Procedures:** Inadequate written gowning procedures