Firm Record

Qualgen LLC findings history

53 findings from 7 inspection documents published by regulators. Each row below says what its date means.

US FDA 2019-04-30 ~ 2026-01-16 7 documents 53 findings

Areas cited

Aseptic processing and sterility assuranceProcess validationDocumentation and recordsLaboratory and QC controlsContamination controlLabeling and packagingQuality unit oversightEquipment and facilityTraining and personnelOther quality systemDeviation, CAPA, and investigationComplaint and recall handlingStability and storageMaterial and supplier control

Published inspection documents

2026-01-16 US FDA 5 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Contamination control Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. 2024-10-07 US FDA 12 findingsEquipment and facility · Quality unit oversight · Aseptic processing and sterility assurance · Labeling and packaging · Process validation · Training and personnel · Documentation and records · Complaint and recall handling Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. 2024-01-17 US FDA 12 findingsQuality unit oversight · Stability and storage · Documentation and records · Labeling and packaging · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Process validation · Contamination control · Training and personnel The responsibilities and procedures applicable to the qualit y control unit are not in writing and fully followed. 2024-01-17 US FDA 5 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Contamination control There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of i ts components to meet any of its specifications whether or not the batch has been already distributed. 2022-11-28 US FDA 6 findingsOther quality system · Material and supplier control · Labeling and packaging · Quality unit oversight · Documentation and records · Laboratory and QC controls Drug products failing to meet established specifications are not rejected. 2022-05-05 US FDA 7 findingsEquipment and facility · Documentation and records · Labeling and packaging · Aseptic processing and sterility assurance Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. 2019-04-30 US FDA 6 findingsEquipment and facility · Process validation · Contamination control · Laboratory and QC controls Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.

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 Qualgen LLC — including inspection classifications Browse by document Go to Findings search