# FDA 483 - Apotex Inc. - September 14, 2022

Source: https://www.keypedia.com/records/483/apotex-inc/30390ae8-4b97-4980-b67e-c38edef4e751

> FDA 483 for Apotex Inc. on September 14, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Apotex Inc.
- Inspection Date: 2022-09-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Apotex Inc. in Richmond Hill, FDA investigators observed that the firm's procedures for preventing microbiological contamination of sterile drug products were not adequately established. Specifically, the firm failed to properly define and document responses to critical interventions on its sterile filling line, which could compromise product sterility.

## Related Documents

- [WARNING_LETTER - 2012-10-26](https://www.keypedia.com/records/warning_letter/apotex-inc/f5a6262b-3ba8-4a19-8a13-996736fefd13)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/apotex-inc/449f09fe-98e2-4f37-8cfd-4c7dd87cbc93)
- [483 - 2025-05-09](https://www.keypedia.com/records/483/apotex-inc/fbae5b29-968d-449a-bc73-daad15615185)
- [483 - 2025-05-09](https://www.keypedia.com/records/483/apotex-inc/999b72dc-ee9d-4a5d-b099-4b96b88b9bc1)

## Related Officers

- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.keypedia.com/companies/apotex-inc/8126714d-6e9a-424d-9e8e-d10f38a8ab7b

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