Inspection Record

Akorn, Inc. — FDA 483 Findings

US FDAInspected 2017-10-13Published 2024-01-17 3 findingsAseptic processing and sterility assuranceEquipment and facilityQuality unit oversight

Inspectors Brian D NicholsonThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drng products pmp orting to be sterile do not include adequate validation ofthe sterilization process.

2Equipment and facility

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.

3Quality unit oversight

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

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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

2016-11-22 · US FDA · 6 findings2015-07-11 · US FDA · 13 findings2015-07-11 · US FDA · 8 findings2017-10-13 · US FDA · 3 findings2018-05-16 · US FDA · 13 findings2018-08-30 · US FDA · 11 findings
Akorn, Inc. company profile — full history US FDA documents, 2024 Go to Findings search