# FDA 483 - Dr. Reddy’s Laboratories Limited - July 18, 2025

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/8dac255a-f01f-4ca0-b11a-bc115b577414

> FDA 483 for Dr. Reddy’s Laboratories Limited on July 18, 2025. 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: 2025-07-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Dr. Reddy's Laboratories Limited, a sterile drug manufacturer in Pydibhimavaram, India, revealed significant deficiencies across multiple systems. Observations included inadequate procedures for preventing microbiological contamination, insufficient aseptic process validation, and failures in drug product release testing. The firm also demonstrated issues with equipment qualification, in-process material testing, quality control unit review of batch records, and a systemic failure to thoroughly review and ensure the effectiveness of corrective and preventive actions for deviations and out-of-specification results.

## Related Documents

- [483 - 2022-07-07](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/da825a57-d71c-458f-b9ea-f8ff1569e3f3)
- [483 - 2025-07-18](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/bea4bff8-1837-484a-92af-4a353b5e8c0e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Jigar R. Patel](https://www.globalkeysolutions.net/people/jigar-r-patel/db40ddb1-d737-46eb-a94c-3ecaf6a8de9c)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited/19f1fec5-d1fb-47f3-92bb-7e3e0f0db5d6

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8