# FDA 483 - Dr. Reddy's Laboratories (EU) Ltd. - September 05, 2025

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-eu-ltd/64a19ff6-3ecf-432c-a60a-a5c735187065

> FDA 483 for Dr. Reddy's Laboratories (EU) Ltd. on September 05, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories (EU) Ltd.
- Inspection Date: 2025-09-05
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from September 1-5, 2025, at Dr. Reddy"s Laboratories (EU) Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Mirfield, West Yorkshire, UK, several significant deviations from quality standards were observed. The company failed to establish adequate testing procedures for raw materials and finished APIs, specifically lacking microbial testing assessments for APIs manufactured using water and destined for the U.S. market, and omitting Burkholderia cepacia testing for USP Purified water. The firm also accepted raw material supplier Certificates of Analysis without performing sufficient identity testing or validating the supplier"s analytical methods, raising concerns about material quality. Furthermore, cleaning procedures for API packaging equipment were not adequately validated, with inspectors observing apparent residue on equipment identified as clean, indicating potential cross-contamination risks. A major concern was the inadequacy of the firm"s investigation system for unexplained discrepancies, particularly Out-of-Specification (OOS) results. Recurring OOS findings for impurity stability testing since 2021 were not effectively addressed, leading to product recalls, missed out-of-trend results, and a failure to notify customers of quality issues. Similarly, repeated OOS assay results since 2023 were linked to unaddressed root causes like sonication deficiencies and incorrect glassware, with corrective actions being ineffective or significantly delayed. These observations highlight the need for Dr. Reddy"s Laboratories (EU) Ltd. to implement comprehensive corrective and preventive actions to ensure the quality, purity, and safety of its APIs, adhering to current Good Manufacturing Practices and regulatory requirements.

## Related Documents

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## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-eu-ltd/c328d057-03f2-4963-b5fc-12e55c201be0

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