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# FDA Warns Akorn on Somerset Facility
- URL: https://www.fdaweb.com/fda-warns-akorn-on-somerset-facility/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144418

FDA has issued a Warning Letter to Akorn, Inc., relating to a 2018 [inspection](https://www.fdaweb.com/fda-releases-akorn-fda-483-with-11-observations/) at its Somerset, NJ, drug manufacturing facility. The company [says](http://investors.akorn.com/news-releases/news-release-details/akorn-receives-fda-warning-letter-0?ref=fdaweb.com) it “will respond to the FDA letter within the required 15 working days” and “is committed to resolving the Warning Letter in a comprehensive and effective manner.” The FDA-483 listed 11 inspection observations.