# FDA 483 - Apotex Inc. - May 09, 2025

Source: https://www.keypedia.com/records/483/apotex-inc/fbae5b29-968d-449a-bc73-daad15615185

> FDA 483 for Apotex Inc. on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apotex Inc.
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Apotex Inc. received a Form 483 citing significant deficiencies across its manufacturing operations, particularly concerning aseptic processing and quality control. Issues included inadequate investigations into product leaks and out-of-specification results, poor equipment maintenance leading to contamination risks, and insufficient procedures for visual inspection and container closure integrity testing. The report also highlighted deficiencies in aseptic process validation, data integrity controls for computerized systems, and the handling of market complaints.

## Related Documents

- [WARNING_LETTER - 2012-10-26](https://www.keypedia.com/records/warning_letter/apotex-inc/f5a6262b-3ba8-4a19-8a13-996736fefd13)
- [483 - 2022-09-14](https://www.keypedia.com/records/483/apotex-inc/30390ae8-4b97-4980-b67e-c38edef4e751)
- [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/999b72dc-ee9d-4a5d-b099-4b96b88b9bc1)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8