# FDA 483 - Apotex Pharmachem Inc. - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/apotex-pharmachem-inc/9bbf8346-eb7e-43f3-ba51-df5354bce5b2

> FDA 483 for Apotex Pharmachem Inc. on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apotex Pharmachem Inc.
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Apotex Pharmachem Inc. in Brantford, Canada, an API manufacturer, identified two significant observations. The firm's validation of a stability-indicating method for an active pharmaceutical ingredient was deemed inadequate, with issues in forced degradation studies. Additionally, the inspection revealed a failure to sign off and lock completed projects in their EMPOWER 3 computerized system, which is contrary to their established standard operating procedures.

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/apotex-pharmachem-inc/7172d87d-ef17-4355-b937-6feea6430add

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1