# FDA EIR - Akom Pharmaceuticals, Inc. - September 17, 2010

Source: https://www.keypedia.com/records/eir/akom-pharmaceuticals-inc/9413489d-6742-410b-9cac-eca8e5e86b5c

> FDA EIR for Akom Pharmaceuticals, Inc. on September 17, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Akom Pharmaceuticals, Inc.
- Inspection Date: 2010-09-17
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: Akorn, Inc. underwent an FDA compliance inspection at its Decatur, IL facility from August 25 to September 17, 2010. Conducted under regulatory frameworks for drug manufacturing, including sterile and animal drug production, this follow-up inspection assessed various quality systems. While the firm addressed many deficiencies from a prior 2009 inspection, the 2010 review identified eight new and continuing issues. Key violations included failing to reject drug products that did not meet established specifications, such as exceeding validated light exposure or hold times, and subsequently distributing these products. The company also used expired raw materials in manufacturing and released products without adequate stability data to support expiration dating. Further deficiencies involved insufficient investigation of failed batches, releasing products before complete testing, and failures in following and maintaining comprehensive written procedures for production and control. Akorn's management acknowledged the observations and committed to providing a response detailing corrective actions within 15 days.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/phung-thien-nguyen/7676da23-6648-4767-a6c1-bcd60951fcc6)
- [CDR Carl A. Huffman III](https://www.keypedia.com/people/cdr-carl-a-huffman-iii/c795e3ce-de9a-4567-9bdb-99ba9ac4731a)
- [recipient](https://www.keypedia.com/people/kimberly-j-wasserkrug/df288d58-94b3-4cf1-ae82-feb179e2b114)

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