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# Akorn ’483s Released
- URL: https://www.fdaweb.com/akorn-483s-released/
- Published: 2017-10-18T12:00:00.000Z
- Updated: 2026-09-14T22:56:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139906

FDA has released two identical FDA-483s issued [4/26](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM580444?ref=fdaweb.com) and [5/3 ](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM580342?ref=fdaweb.com)following a 4/20-4/26 agency inspection at Akorn, Inc., Decatur, IL. The inspection observations were: 

- the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- 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; and
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.