# FDA 483 - Akom Pharmaceuticals, Inc. - April 26, 2017

Source: https://www.globalkeysolutions.net/records/483/akom-pharmaceuticals-inc/79ab9a8e-a57d-4bbf-8f14-1a0e702214ea

> FDA 483 for Akom Pharmaceuticals, Inc. on April 26, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akom Pharmaceuticals, Inc.
- Inspection Date: 2017-04-26
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Akorn, Inc. in Decatur, IL, revealed significant deficiencies in their sterile drug manufacturing operations. Observations included a failure of the quality control unit to follow written procedures, issues with equipment design leading to particle contamination on a vial staging mechanism, and inadequate validation of sterilization processes for sterile drug products. These findings indicate serious concerns regarding the firm's control over aseptic processing and product quality.

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## Related Officers

- [Brian D. Nicholson](https://www.globalkeysolutions.net/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

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

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