Inspection Record

Dr. Reddy’s Laboratories Limited — FDA 483 Findings

US FDAInspected 2025-12-12Published 2026-01-05 5 findingsProcess validationDeviation, CAPA, and investigationMaterial and supplier controlLaboratory and QC controlsEquipment and facility

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

Findings

1Process validation

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy a its components to meet any of its specifications whether or not the bat Specifically, A.

3Material and supplier control

Written procedures are not followed for the sampling of drug substance and excipients.

4Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

5Equipment and facility

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

About this record

Extracted automatically from the document US FDA published on 2026-01-05. 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

2019-02-08 · US FDA · 11 findings
Dr. Reddy’s Laboratories Limited company profile — full history US FDA documents, 2026 Go to Findings search