Firm Record

Alkem Laboratories Limited findings history

28 findings from 3 inspection documents published by regulators. Each row below says what its date means.

US FDA 2016-11-29 ~ 2026-07-27 3 documents 28 findings

Areas cited

Equipment and facilityQuality unit oversightProcess validationOther quality systemComplaint and recall handlingLaboratory and QC controlsStability and storageDeviation, CAPA, and investigationContamination controlMaterial and supplier control

Published inspection documents

2026-07-27 US FDA 7 findingsQuality unit oversight · Complaint and recall handling · Material and supplier control · Equipment and facility · Process validation · Deviation, CAPA, and investigation The responsibilities and procedures applicable to the quality control unit are not fully followed. 2018-04-11 US FDA 10 findingsQuality unit oversight · Other quality system · Process validation · Equipment and facility · Laboratory and QC controls · Stability and storage The responsibilities and procedures applicable to the quality control unit are not fully followed. 2016-11-29 US FDA 11 findingsQuality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Other quality system · Complaint and recall handling · Contamination control The responsibilities and procedures applicable to the quality control unit are not in writing and 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 Alkem Laboratories Limited — including inspection classifications Browse by document Go to Findings search