# FDA 483 - Accugen Laboratories, Inc. - April 22, 2022

Source: https://www.keypedia.com/records/483/accugen-laboratories-inc/c5bf4b00-bc67-45a7-9144-edb489163b2f

> FDA 483 for Accugen Laboratories, Inc. on April 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accugen Laboratories, Inc.
- Inspection Date: 2022-04-22
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Accugen Laboratories, Inc. in Addison, IL, a contract laboratory, revealed significant deficiencies in laboratory controls and record-keeping. The firm failed to demonstrate the suitability of its USP71-Sterility Test method and lacked a proper quality agreement with its sponsor. Additionally, laboratory records were found to be incomplete, missing analyst initials, dates, and clear time notations.

## Related Documents

- [483 - 2024-02-13](https://www.keypedia.com/records/483/accugen-laboratories-inc/57c3577a-92cb-4bcc-85e6-0dcad0f722d3)

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Norman K. Starks](https://www.keypedia.com/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.keypedia.com/companies/accugen-laboratories-inc/d5abee17-b86a-4c91-9564-5b537d1541a0

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