# FDA 483 - Dr. Reddy's Laboratories Ltd, CTO Unit 1 - May 05, 2023

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd-cto-unit-1/4488c53f-9cb5-4140-a414-b1b99644569e

> FDA 483 for Dr. Reddy's Laboratories Ltd, CTO Unit 1 on May 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd, CTO Unit 1
- Inspection Date: 2023-05-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Dr. Reddy's Laboratories Ltd, CTO Unit 1 in Sangareddy, India, revealed a significant issue regarding the testing and storage of components. The firm failed to adequately assess storage conditions for a highly hygroscopic material, potentially impacting the quality of an active pharmaceutical ingredient. This indicates a lapse in quality control practices for raw materials.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/dr-reddys-laboratories-ltd-cto-unit-1/6b22d2c7-7fa8-4df8-903f-4775c508dc57

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