# FDA 483 - Patheon Inc. - February 17, 2023

Source: https://www.keypedia.com/records/483/patheon-inc/f9bce56c-ec13-47fb-acac-4981f4b62426

> FDA 483 for Patheon Inc. on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Patheon Inc.
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Patheon Inc., a contract manufacturer in Whitby, was cited for inadequate testing and release procedures for drug products. The firm failed to perform appropriate laboratory determination of identity and strength for active ingredients, specifically for a drug substance used in tablets distributed to the US market, by not conducting full testing per the supplier's Certificate of Analysis.

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)
- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/patheon-inc/76561a83-edb8-4c76-934b-6b2bd5e67949

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