Firm Record

Glenmark Pharmaceuticals Ltd. findings history

24 findings from 6 inspection documents published by regulators. Each row below says what its date means.

US FDA 2017-12-05 ~ 2025-07-22 6 documents 24 findings

Areas cited

Laboratory and QC controlsDeviation, CAPA, and investigationProcess validationDocumentation and recordsEquipment and facilityQuality unit oversightTraining and personnelComplaint and recall handlingStability and storageComputer system validation

Published inspection documents

2025-07-22 US FDA 3 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm failed to perform method validation (or verification, as appropriate) of test methods to… 2025-03-06 US FDA 3 findingsDeviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. 2022-12-28 US FDA 4 findingsDocumentation and records · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls Batch production and conti·ol records do not include complete info1mation relating to the production and conti-ol of each batch. 2022-12-06 US FDA 4 findingsDeviation, CAPA, and investigation · Laboratory and QC controls · Process validation · Documentation and records 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). A. Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings. From 2018 to 2021, you rejected 14 batches of 0.1mg and 0.2mg strength desmopressin acetate… 2018-06-05 US FDA 4 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that conform to appropriate standards of identity, strength, quality and purity. 2017-12-05 US FDA 6 findingsQuality unit oversight · Process validation · Complaint and recall handling · Computer system validation · Training and personnel Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards ofeach drug product to determine the need for changes in specifications or manufacturing or control procedures.

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 Glenmark Pharmaceuticals Ltd. — including inspection classifications Browse by document Go to Findings search