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# Akorn Pharmaceuticals Inspection Observations
- URL: https://www.fdaweb.com/akorn-pharmaceuticals-inspection-observations/
- Published: 2016-10-19T12:00:00.000Z
- Updated: 2026-09-14T21:41:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137114

A just-released FDA-483 details observations from a 6/1-6/10 inspection of Akorn Pharmaceuticals, Decatur, IL. Specific [observations](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm525311.pdf?ref=fdaweb.com) included: 

- failing to record and justify deviations from written production and process control procedures;
- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to extend investigations of a failure of a batch or any of its components to meet any of its specifications to other drug products that may have been associated with the specific failure or discrepancy;
- failing to have quality controls include a determination of conformance to written descriptions of sampling procedures for drug products;
- failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to verify under actual conditions of use the suitability of all testing methods; and
- failing to establish control procedures that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.