Firm Record

Dr. Reddy's Laboratories Ltd. findings history

70 findings from 13 inspection documents published by regulators. Each row below says what its date means.

US FDAHealth Canada 2017-05-04 ~ 2025-10-27 13 documents 70 findings

Areas cited

Material and supplier controlDeviation, CAPA, and investigationEquipment and facilityQuality unit oversightLaboratory and QC controlsAseptic processing and sterility assuranceComplaint and recall handlingComputer system validationProcess validationTraining and personnelOther quality systemDocumentation and recordsCleaning validationStability and storageContamination control

Published inspection documents

2025-10-27 US FDA 4 findingsDeviation, CAPA, and investigation · Quality unit oversight · Equipment and facility Written records of investigations into unexplained discrepancies do not always include the conclusion and follow- up. 2025-08-07 US FDA 6 findingsAseptic processing and sterility assurance · Other quality system · Equipment and facility · Material and supplier control · Quality unit oversight · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not written. 2024-09-16 Health Canada 4 findingsMaterial and supplier control · Complaint and recall handling · Computer system validation The protection of products and/or materials from contamination was inadequate. 2023-12-28 US FDA 3 findingsTraining and personnel · Laboratory and QC controls Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices. 2023-11-29 US FDA 9 findingsOther quality system · Equipment and facility · Complaint and recall handling · Laboratory and QC controls · Computer system validation · Quality unit oversight · Process validation Detenninations of confonnance to appropriate written specifications for acceptance are deficient for diug products. 2023-05-29 Health Canada 5 findingsComplaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Material and supplier control The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. 2021-12-06 US FDA 7 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Laboratory and QC controls · Contamination control There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 2019-08-29 US FDA 8 findingsDeviation, CAPA, and investigation · Process validation · Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 2019-02-26 US FDA 4 findingsProcess validation · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls Written production and process control procedures are not followed in the execution ofproduction and process control functions and documented at the time of performance. 2018-11-14 US FDA 5 findingsDeviation, CAPA, and investigation · Training and personnel · Aseptic processing and sterility assurance · Documentation and records There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed { | Specifically, your Quality Unit failed to conduct a comprehensive evaluation and implement appropriate and | effective corrective and preventive actions to prevent reoccurrence of aborted HPLC sequence events. 2018-03-21 US FDA 3 findingsComplaint and recall handling · Material and supplier control · Equipment and facility Procedures describing the handling of written and oral complaints related to AP] materials are not followed. 2017-09-26 US FDA 3 findingsMaterial and supplier control · Cleaning validation · Other quality system Manually managed materials in the warehouse are not separated during storage. 2017-05-04 US FDA 9 findingsQuality unit oversight · Laboratory and QC controls · Material and supplier control · Training and personnel · Equipment and facility · Computer system validation The responsibilities and procedures applicable to the quality control unit are not fully followed.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Dr. Reddy's Laboratories Ltd. — including inspection classifications Browse by document Go to Findings search