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

Source: https://www.keypedia.com/records/483/apotex-inc/ad87e251-1d7a-46bb-b84a-524a99320522

> 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: Foreign - CDER (Non-Bioresearch Monitoring)
- Summary: I am sorry, but I cannot create a concise summary of the FDA 483 document as the actual content of the document was not provided. The input only contained a list of page numbers (e.g., "Page 1 of 24"). To generate the summary, I would need the full text of the FDA 483 document, including details about the company name, inspection dates, specific observations regarding violations or issues, the relevant regulatory framework, and any implied or explicit required actions. Please provide the complete document content for me to process your request.

## Related Documents

- [483 - 2025-05-09](https://www.keypedia.com/records/483/apotex-inc/e9e0e012-73b2-4b00-9d90-c8c5e453781a)

## Related Officers

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

Company: https://www.keypedia.com/companies/apotex-inc/8e602fdb-1eea-40e1-978a-47dd1b1ef7e2

Office: https://www.keypedia.com/offices/foreign-cder-non-bioresearch-monitoring/279f5818-f62e-40c9-951c-cfbc7f929fa1