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# Dr. Reddy’s Hit with 7-Item FDA-483
- URL: https://www.fdaweb.com/dr-reddys-hit-with-7-item-fda-483/
- Published: 2025-10-27T12:00:00.000Z
- Updated: 2026-09-14T15:25:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160107

FDA has posted a seven-item [Form FDA-483](https://www.fda.gov/media/189354/download?ref=fdaweb.com) after inspecting Dr. Reddy’s Mirfield, West Yorkshire, UK, active pharmaceutical ingredient (API) manufacturing facility 9/1-5/2025\. The key GMP deficiencies noted were:

- Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw material and APIs meet accepted quality standards and are consistent with the manufacturing process.
- Certificates of analysis from raw material suppliers are accepted in lieu of testing each component for conformance to written specifications.
- Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
- Written records of investigations into unexplained discrepancies do not always include the conclusion and follow-up.
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Document control procedures under quality unit oversight are inadequate.
- Manually managed materials in the warehouse and facilities are not separated during storage.

This is the second Dr. Reddy’s 483 released this month by FDA. The agency issued a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility last month in Telangana, India ([see story](https://www.fdaweb.com/5-items-in-dr-reddys-form-fda-483/)).