# FDA 483 - Athenex Pharma Solutions, LLC - August 28, 2019

Source: https://www.keypedia.com/records/483/athenex-pharma-solutions-llc/69ff5972-5572-4bb4-9e51-c080e39490f9

> FDA 483 for Athenex Pharma Solutions, LLC on August 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athenex Pharma Solutions, LLC
- Inspection Date: 2019-08-28
- Product Type: Drugs
- Office Name: New Jersey 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. The inspection was conducted from August 19, 2019, to August 28, 2019. Robert Keem, General Manager, was the individual to whom the report was issued.

The inspection revealed one observation: Written production and process control procedures were not followed in the execution of production and process control functions.

Specifically:
A. On August 20, 2019, during the manufacturing of Norepinephrine 1mg/ml, Lot# S1900185, an operator did not wipe down all work surfaces and equipment with a clean room wipe thoroughly wetted with (b)(4), contrary to SOP No. APS-SOP-0344 "503B Bulk Formulation-(b)(4) and Sealing Process."
B. On August 23, 2019, during the manufacturing of Neostigmine Methylsulfate 5mg/5ml syringe, Lot# F1900899, an operator was observed wiping the bottom of the container (b)(4) with the (b)(4) cloth during drug production in the ISO 5 classified area, which deviates from SOP No. APS

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## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248