Firm Record

Intas Pharmaceuticals Limited findings history

50 findings from 5 inspection documents published by regulators. Each row below says what its date means.

US FDA 2017-07-19 ~ 2023-11-28 5 documents 50 findings

Areas cited

Laboratory and QC controlsQuality unit oversightProcess validationOther quality systemAseptic processing and sterility assuranceDeviation, CAPA, and investigationComputer system validationEquipment and facilityContamination controlTraining and personnelData integrityDocumentation and recordsStability and storageEnvironmental monitoring

Published inspection documents

2023-11-28 US FDA 4 findingsAseptic processing and sterility assurance · Process validation · Quality unit oversight Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations. You lacked investigations into visual inspection failures and non-viable particulates (NVP) exceeding your action… 2023-08-01 US FDA 12 findingsEnvironmental monitoring · Data integrity · Computer system validation · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation Our investigators observed plastic bags filled with torn and discarded original CGMP documents in your quality control (QC) scrap area under a stairwell, in your general parenteral scrap room, and on a truck outside your facility. Among these CGMP documents were engineering checklists associated with the Environmental Monitoring System (EMS), torn Karl Fischer (KF) analytical test reports, auto titration curves, and analytical balance weight slips for finished drug products. 2023-07-05 US FDA 16 findingsAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Computer system validation · Other quality system · Laboratory and QC controls · Documentation and records · Contamination control · Deviation, CAPA, and investigation · Process validation Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 2023-01-18 US FDA 11 findingsStability and storage · Deviation, CAPA, and investigation · Quality unit oversight · Computer system validation · Laboratory and QC controls · Process validation · Aseptic processing and sterility assurance · Other quality system Results of stability testing are not used in dete1mining. 2017-07-19 US FDA 7 findingsQuality unit oversight · Equipment and facility · Laboratory and QC controls · Contamination control · Training and personnel The quality control unit lacks responsibility to approve all procedures or specifications impacting the quality of drug products.

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 Intas Pharmaceuticals Limited — including inspection classifications Browse by document Go to Findings search