# FDA 483 - Akom Pharmaceuticals, Inc. - April 08, 2022

Source: https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/575fc564-59ca-4099-a83e-ad944b55117b

> FDA 483 for Akom Pharmaceuticals, Inc. on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akom Pharmaceuticals, Inc.
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Akorn, Inc. in Decatur, IL, a sterile drug manufacturer, revealed significant deficiencies across its quality systems. Observations included failures to follow procedures designed to prevent microbiological contamination, inadequate investigations into unexplained discrepancies and product failures, and a lack of written procedures for critical production and process controls. These issues suggest a systemic breakdown in maintaining product quality and purity.

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## Related Officers

- [Jacob S Katz](https://www.keypedia.com/people/jacob-s-katz/823dee02-1628-4009-8aff-a93d2295442f)
- [Eboni Funderburk](https://www.keypedia.com/people/eboni-funderburk/9907e6b1-a396-45b8-b85c-59a451a2cb8d)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Sean T Grigsby](https://www.keypedia.com/people/sean-t-grigsby/a46ab517-430d-496e-adef-2d520f4f64af)

Company: https://www.keypedia.com/companies/akom-pharmaceuticals-inc/ac503050-70db-46c3-accc-c945413cfae1

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669