# FDA 483 - Duchesnay Inc. - October 27, 2023

Source: https://www.globalkeysolutions.net/records/483/duchesnay-inc/a50f07a3-4e07-4cd8-9385-1c7501135912

> FDA 483 for Duchesnay Inc. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Duchesnay Inc.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Duchesnay Inc., a nonsterile finished drug product manufacturer in Blainville, was inspected by the FDA from October 23-27, 2023. The inspection revealed a significant deficiency in the firm's production and process controls. Specifically, the company failed to establish adequate written procedures and critical process parameters for its tableting operations, impacting the assurance of drug product identity, strength, purity, and quality.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/duchesnay-inc/b48797ea-bce2-4e75-a2cd-4e6b3a5f722c

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