# FDA 483 - Akorn Operating Company LLC - March 28, 2026

Source: https://www.keypedia.com/records/483/akorn-operating-company-llc/336425ad-3848-4530-a212-0c2e4310100c

> FDA 483 for Akorn Operating Company LLC on March 28, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akorn Operating Company LLC
- Inspection Date: 2026-03-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Akorn Inc, a sterile drug manufacturer in Somerset, NJ, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant issues across quality control, including failures in preventing microbiological contamination, inadequate investigations, and a deficient stability testing program. Additionally, the firm was cited for poor data documentation practices, unapproved changes to validation protocols, and a lack of proper method verification, transfer, and validation for various drug products and cleaning processes.

## Related Documents

- [483 - 2011-05-19](https://www.keypedia.com/records/483/akorn-operating-company-llc/33f07cfa-8d29-4739-a692-6149de2c6823)
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- [483 - 2022-05-17](https://www.keypedia.com/records/483/akorn-operating-company-llc/d63e63b2-5402-4ae2-b321-7074d8a6947a)

## Related Officers

- [Senior Compliance Officer](https://www.keypedia.com/people/barbara-wilimczyk-macri/36eda42e-09b6-4364-a000-c5cd8ddb70ee)
- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/akorn-operating-company-llc/347ed7e7-51c4-481b-b84c-3055f99d6288

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248