Firm Record
Lupin Limited findings history
78 findings from 12 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Equipment and facilityDeviation, CAPA, and investigationOther quality systemLaboratory and QC controlsComplaint and recall handlingComputer system validationQuality unit oversightProcess validationTraining and personnelAseptic processing and sterility assuranceMaterial and supplier controlCleaning validationStability and storageContamination controlRegulatory reporting and change controlDocumentation and records
Published inspection documents
2026-02-18
US FDA
6 findingsComplaint and recall handling · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Laboratory and QC controls Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
2026-01-21
US FDA
6 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Other quality system The v.,ritten stability program for dmg products does not include reliable, meaningful and specific test methods.
2025-03-03
Health Canada
6 findingsEquipment and facility · Contamination control · Stability and storage · Other quality system The maintenance of the premises was inadequate. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
2023-04-19
US FDA
10 findingsDeviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Training and personnel · Computer system validation · Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls (Repeat) There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
2023-04-14
US FDA
10 findingsDeviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Quality unit oversight · Laboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Training and personnel Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other diug products that may have been associated with the specific failure or discrepancy.
2023-03-13
Health Canada
8 findingsMaterial and supplier control · Cleaning validation · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Complaint and recall handling Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
2023-03-09
Health Canada
4 findingsOther quality system · Regulatory reporting and change control · Stability and storage · Equipment and facility The recorded information or details were inadequate.
2022-11-01
US FDA
3 findingsCleaning validation · Deviation, CAPA, and investigation · Other quality system Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API. Your firm performed multiple risk assessments with the purpose to verify whether existing cleaning procedures and practices eliminate or reduce genotoxic impurities, including (b)(4) and (b)(4) impurities, generated through the manufacture of (b)(4) drugs, after you detected (b)(4) impurities in your API. You also performed risk assessments…
2020-02-04
US FDA
4 findingsMaterial and supplier control · Deviation, CAPA, and investigation · Other quality system · Process validation Samples from incoming raw materials should be collected from top, middle, bottom of the raw material containers to represent the entire content of the container.
2019-02-08
US FDA
6 findingsDeviation, CAPA, and investigation · Laboratory and QC controls · Complaint and recall handling · Computer system validation · Training and personnel · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
2017-06-02
US FDA
6 findingsDeviation, CAPA, and investigation · Equipment and facility · Process validation · Documentation and records There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
2016-11-29
US FDA
9 findingsDeviation, CAPA, and investigation · Equipment and facility · Contamination control · Material and supplier control · Other quality system · Laboratory and QC controls · Process validation There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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.
