Inspection Record

Akorn, Inc. — FDA 483 Findings

US FDAInspected 2016-11-22Published 2025-06-20 6 findingsLaboratory and QC controlsProcess validationDeviation, CAPA, and investigationQuality unit oversight

Inspectors Patrie C. Klotzbuecher · Samina S. Khan · Anastasia M. ShieldsThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

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.

2Process validation

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

3Laboratory and QC controls

The suitability of all testing methods is not verified under actual conditions of use.

4Deviation, CAPA, and investigation

Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.

5Deviation, CAPA, and investigation

Deviations from written production and process control procedures are not recorded and justified.

6Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

About this record

Extracted automatically from the document US FDA published on 2025-06-20. The source is available at the link above.

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.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2015-07-11 · US FDA · 13 findings2015-07-11 · US FDA · 8 findings2017-10-13 · US FDA · 3 findings2017-10-13 · US FDA · 3 findings2018-05-16 · US FDA · 13 findings2018-08-30 · US FDA · 11 findings
Akorn, Inc. findings history — including this company's other documents US FDA documents, 2025 Go to Findings search