# FDA 483 - Akom Pharmaceuticals, Inc. - April 09, 2026

Source: https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/c101467e-2c76-4953-9db6-96401f0c785e

> FDA 483 for Akom Pharmaceuticals, Inc. on April 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akom Pharmaceuticals, Inc.
- Inspection Date: 2026-04-09
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Akorn, Inc. received a Form 483 citing numerous deficiencies across its manufacturing operations. Key issues include poor aseptic processing techniques, inadequate environmental monitoring, failure to report critical changes and product issues, and insufficient investigations into discrepancies. The observations highlight systemic problems with quality control, data integrity, equipment design, and employee training, many of which are repeat observations from previous inspections.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/12e3d2af-57a4-4808-a931-35f4c4279df3)
- [483 - 2022-04-08](https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/575fc564-59ca-4099-a83e-ad944b55117b)
- [EIR - 2010-09-17](https://www.keypedia.com/records/eir/akom-pharmaceuticals-inc/9413489d-6742-410b-9cac-eca8e5e86b5c)
- [483 - 2016-06-10](https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/cb6c4b93-d022-4f72-a486-96745f11a342)
- [483 - 2018-05-16](https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/59e43e0f-88d9-4b22-911b-0af134c2877d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

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