# FDA 483 - Dr Reddy's Laboratories Limited - August 23, 2024

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited/4ebd243f-4c5b-43ea-afa9-7af5a36b491a

> FDA 483 for Dr Reddy's Laboratories Limited on August 23, 2024. 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: 2024-08-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Dr. Reddy's Laboratories Limited in Devunipalavalasa, India, revealed significant deficiencies in laboratory controls, discrepancy investigations, and computer system management. The firm failed to establish scientifically sound specifications, thoroughly review out-of-trend results and deviations, and maintain adequate controls over computer systems, indicating a lack of robust quality assurance practices.

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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited/97f3d461-62f0-4198-9e9d-7f7c7d43af86

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