# FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - September 12, 2025

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd-biologics/59abc27c-8a48-4f4b-b1f1-bf1141ca225a

> FDA 483 for Dr. Reddy's Laboratories, Ltd, Biologics on September 12, 2025. 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: 2025-09-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Dr. Reddy's Laboratories, LTD, Biologics, a drug substance and drug product manufacturer in Telangana, India, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality unit oversight of environmental monitoring data, poor document control practices, and critical failures in aseptic processing techniques. These issues collectively indicate a lack of robust controls to ensure product quality and sterility.

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## Related Officers

- [Jiangsong Jiang](https://www.keypedia.com/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/baikuntha-aryal/9ef7cae9-ad10-49af-bcaa-8b23a1b3cbe8)
- [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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8