Inspection Record

Akorn AG — FDA 483 Findings

US FDAInspected 2017-12-12Published 2018-05-03 3 findingsStability and storageEquipment and facilityLaboratory and QC controls

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

Findings

2Equipment and facility

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

3Laboratory and QC controls

The accuracy, sensitivity and reproducibility of test methods have not been established and documented.

About this record

Extracted automatically from the document US FDA published on 2018-05-03. 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.

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