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# FDA Releases Akorn FDA-483 with 11 Observations
- URL: https://www.fdaweb.com/fda-releases-akorn-fda-483-with-11-observations/
- Published: 2018-11-06T12:00:00.000Z
- Updated: 2026-09-15T00:42:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142750

FDA has released the FDA-483 issued following a 7/23-8/30 inspection at Akorn, a Somerset, NJ, sterile drug manufacturer. It was the latest in a string of issues the company has faced. The 11 specific observations on the [form](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm624887.pdf?ref=fdaweb.com) were: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy;
- responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- written stability testing program is not followed;
- appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- procedures describing the calibration of instruments, apparatus, gauges, and recording devices are not written or followed;
- laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy;
- laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
- procedures for 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
- drug product samples are not properly identified.

Akorn has multiple 2018 inspection observations at manufacturing facilities in [Decatur, IL](https://www.fdaweb.com/13-observations-in-akorn-inspection-fda-483/), and [Zurich, Switzerland](https://www.fdaweb.com/akorn-form-483-posted-from-zurich-2016-inspection/), and a [second](https://www.fdaweb.com/akorn-ag-fda-483-released/) inspection at the Zurich facility. There are also reports from two 2017 inspections at the Decatur facility, [here](https://www.fdaweb.com/akorn-483s-released/) and [here](https://www.fdaweb.com/akorn-pharmaceuticals-inspection-observations/).