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# Akorn Form 483 Posted from Zurich 2016 Inspection
- URL: https://www.fdaweb.com/akorn-form-483-posted-from-zurich-2016-inspection/
- Published: 2018-05-07T12:00:00.000Z
- Updated: 2026-09-15T00:02:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141378

FDA has posted an Akorn Form 483 from a 2016 inspection at the firm’s Zurich, Switzerland sterile drug manufacturing facility. The [five-item 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM606831.pdf?ref=fdaweb.com) cited the firm for failing to thoroughly review any unexplained discrepancy. It was also cited for not having the quality control unit’s responsibilities and procedures in writing. And it was cited for not establishing and following procedures to prevent microbiological contamination.