# FDA 483 - Athenex Pharma Solutions, LLC - December 13, 2017

Source: https://www.keypedia.com/records/483/athenex-pharma-solutions-llc/d2193dba-72bb-4a6c-a23d-e740f15fdb92

> FDA 483 for Athenex Pharma Solutions, LLC on December 13, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athenex Pharma Solutions, LLC
- Inspection Date: 2017-12-13
- Office Name: New York District Office
- Summary: This FDA Form 483 was issued to Athenex Pharma Solutions, LLC, an outsourcing facility located at 11342 Main St, Clarence, NY 14031-1718, following an inspection from December 5 to December 13, 2017. Robert F. Keem, General Manager, was the individual to whom the report was issued.

The inspection revealed four observations:

1.  **Deficient Aseptic Processing Area Cleaning/Disinfection:** An operator was observed on December 6, 2017, disinfecting an ISO 5 Laminar Flow Hood with an incorrect disinfectant and in a manner inconsistent with the firm's procedure and smoke studies. The procedure requires disinfection from the cleanest to the dirtiest area, which was not followed.

2.  **Deficient Environmental Monitoring:** On December 6, 2017, no environmental monitoring sampling was performed in the ISO 5 area where an operator was working. The firm's media fill validations and environmental monitoring procedure state that viable monitoring should be performed in the ISO 5 area, but it is only performed in the ISO 7 area.

3.  **Inadequate Temperature Control for Drug Product Storage:** The firm's temperature-monitored area does not cover all locations where approved human finished drug products (active ingredients) are stored. While temperature probes are in the (b)(4) area of

## Related Documents

- [483 - 2017-12-13](https://www.keypedia.com/records/483/athenex-pharma-solutions-llc/42545465-cfb4-4f25-810a-8d1cefa248f0)
- [OTHER_CORRESPONDENCE - 2017-12-13](https://www.keypedia.com/records/other_correspondence/athenex-pharma-solutions-llc/319d25f9-a0f3-47a8-9cb3-b441e70f1a02)
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## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-a-moliver/6130c1d8-9867-4da5-b113-1bbaf0ae9c79)

Company: https://www.keypedia.com/companies/athenex-pharma-solutions-llc/d8bf380f-b613-4bd7-831f-33a576776e21

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d