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# Akorn AG FDA-483 Released
- URL: https://www.fdaweb.com/akorn-ag-fda-483-released/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141354

FDA has released the FDA-483 issued following a 12/4-12/12/17 inspection at Akorn AG, Zurich, Switzerland, a finished drug product manufacturer. The four inspection [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM606557.pdf?ref=fdaweb.com) were: 

- failing to establish and document the accuracy, sensitivity, and reproducibility of test methods;
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products;
- 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; and
- failing to follow the written stability testing program.

In a recent court filing, Fresenius [said](https://www.fdaweb.com/fresenius-decision-to-abandon-akorn-deal-based-on-blatant-fraud/) it terminated its $4.7 billion merger agreement with Akorn due to alleged “blatant fraud at the very top level” of Akorn. Fresenius said it found material breaches of FDA data integrity requirements relating to Akorn’s operations found during Fresenius’ independent investigation.