Firm Record

Akorn, Inc. findings history

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

US FDA 2019-04-30 ~ 2025-06-20 7 documents 57 findings

Areas cited

Quality unit oversightAseptic processing and sterility assuranceEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationProcess validationOther quality systemMaterial and supplier controlDocumentation and recordsComplaint and recall handlingStability and storageTraining and personnelComputer system validation

Published inspection documents

2025-06-20 US FDA 6 findingsLaboratory and QC controls · Process validation · 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 in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. 2024-01-17 US FDA 13 findingsOther quality system · Aseptic processing and sterility assurance · Complaint and recall handling · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Documentation and records · Material and supplier control Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not followed. 2024-01-17 US FDA 8 findingsMaterial and supplier control · Process validation · Documentation and records · Quality unit oversight · Laboratory and QC controls · Stability and storage Written procedures are lacking which describe in sufficient detail the testing, approval, and rejection of components, drug product containers, and closures. 2024-01-17 US FDA 3 findingsEquipment and facility · Quality unit oversight · Aseptic processing and sterility assurance Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance. 2024-01-17 US FDA 3 findingsAseptic processing and sterility assurance · Equipment and facility · Quality unit oversight Procedures designed to prevent microbiological contamination of drng products pmp orting to be sterile do not include adequate validation ofthe sterilization process. 2019-04-30 US FDA 13 findingsOther quality system · Deviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Material and supplier control · Equipment and facility · Complaint and recall handling Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertainng to data retention and management. 2019-04-30 US FDA 11 findingsDeviation, CAPA, and investigation · Quality unit oversight · Computer system validation · Stability and storage · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Other quality system 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.

Full history of Akorn, Inc. — including inspection classifications Browse by document Go to Findings search