# FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - June 25, 2026

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd-biologics/6f62d6c9-4fac-4d04-99a1-b64bf4b9f8b5

> FDA 483 for Dr. Reddy's Laboratories, Ltd, Biologics on June 25, 2026. 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: 2026-06-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Dr. Reddy's Laboratories Ltd. in Bachupally, India, was cited for severe deficiencies in aseptic processing during drug product and drug substance manufacturing. Observations included inadequate aseptic practices during filling, insufficient environmental monitoring, microbial contamination in intermediates, and a flawed visual inspection program. The firm also failed to adequately review bioburden testing results and provide sufficient training for aseptic operators, indicating a systemic lack of control over sterility assurance.

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## Related Officers

- [Ayyappan Rathakrishnan](https://www.keypedia.com/people/ayyappan-rathakrishnan/4f1e717b-5d46-4f94-83c8-59eff245cc44)
- [Alexander R. Sohr](https://www.keypedia.com/people/alexander-r-sohr/51b905a3-cbf1-4023-8871-a5b8a9d94152)
- [Maria G. Gutierrez-Hoffman](https://www.keypedia.com/people/maria-g-gutierrez-hoffman/4a740635-49a6-451b-b002-416a00eb7d1f)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4