# FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - October 12, 2023

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd-biologics/2e14452f-b6da-4c34-8c6a-195f6ab1404f

> FDA 483 for Dr. Reddy's Laboratories, Ltd, Biologics on October 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories, Ltd, Biologics
- Inspection Date: 2023-10-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Dr. Reddy's Laboratories, Ltd, Biologics in Hyderabad, India, was cited for significant deficiencies in its drug substance and drug product manufacturing processes. The inspection revealed critical issues including inadequate viral control strategies, widespread mold contamination, insufficient investigations into product defects, and a lack of process control and validation for sterilization and cleaning. These findings indicate a severe lack of control over manufacturing operations, posing risks to product quality and patient safety.

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## Related Officers

- [Zhong Zhao](https://www.keypedia.com/people/zhong-zhao/a8543d5d-c319-4e2f-a2e7-b9d25a94a405)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

Company: https://www.keypedia.com/companies/dr-reddys-laboratories-ltd-biologics/945273a9-b82d-4c82-aee6-3e57748cdf0d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd