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

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd/383e5e95-1e2b-441b-99ea-82d2c5b02062

> FDA 483 for Dr. Reddy's Laboratories Ltd. on October 27, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd.
- Inspection Date: 2023-10-27
- Summary: 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

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