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

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/da825a57-d71c-458f-b9ea-f8ff1569e3f3

> FDA 483 for Dr. Reddy’s Laboratories Limited on July 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy’s Laboratories Limited
- Inspection Date: 2022-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited/19f1fec5-d1fb-47f3-92bb-7e3e0f0db5d6

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1