# FDA 483 - Akom Pharmaceuticals, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/akom-pharmaceuticals-inc/12e3d2af-57a4-4808-a931-35f4c4279df3

> FDA 483 for Akom Pharmaceuticals, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akom Pharmaceuticals, Inc.
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Akorn Pharmaceuticals, Inc. in Decatur, IL, was inspected and received a Form 483 with six observations related to significant deficiencies in their sterile drug product manufacturing processes. The observations highlight critical issues across production, quality control, and laboratory systems, including failures in recording deviations, inadequate batch record reconciliation, insufficient investigation of batch failures, and scientifically unsound sampling and environmental monitoring practices. These findings indicate a lack of robust controls necessary to ensure the quality and sterility of their drug products.

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## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Samina S. Khan](https://www.keypedia.com/people/samina-s-khan/ca3e266c-aa69-4c28-9901-d344e0c259fd)
- [Patric C. Klotzbuecher](https://www.keypedia.com/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

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