Inspection Record

Dr. Reddy's Laboratories — FDA 483 Findings

US FDAInspected 2025-09-05Published 2025-10-27 4 findingsDeviation, CAPA, and investigationQuality unit oversightEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusion and follow- up.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

3Equipment and facility

Manually managed materials in the warehouse and facilities are not separated during storage.

4Quality unit oversight

Document control procedures under Quality Unit oversight are inadequate.

About this record

Extracted automatically from the document US FDA published on 2025-10-27. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2025-07-18 · US FDA · 6 findings2024-09-16 · Health Canada · 4 findings2023-12-08 · US FDA · 3 findings2023-10-27 · US FDA · 9 findings2023-05-29 · Health Canada · 5 findings2021-10-29 · US FDA · 7 findings
Dr. Reddy's Laboratories company profile — full history US FDA documents, 2025 Go to Findings search