# FDA 483 - Dr Reddy's Laboratories Limited - December 08, 2023

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited/fb32f529-19a9-4a4e-a007-4098699a5054

> FDA 483 for Dr Reddy's Laboratories Limited on December 08, 2023. 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: 2023-12-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Dr Reddy's Laboratories Limited in Bachupally, India, revealed significant deficiencies in laboratory record-keeping, data integrity, and quality control procedures for complex analytical testing. The firm also failed to ensure employees received required training in GMP activities. These issues indicate a concerning lack of robust quality systems for drug product testing and data management.

## Related Documents

- [483 - 2023-12-08](https://www.keypedia.com/records/483/dr-reddys-laboratories-limited/b5eeaff1-a473-4a99-98d0-5162cc8409bd)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited/b8bf1054-aff5-4e43-8319-48f33c09d531

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