# FDA 483 - Les Produits Chimiques B.G.R., Inc. - February 28, 2025

Source: https://www.globalkeysolutions.net/records/483/les-produits-chimiques-bgr-inc/49b224bd-d4fe-444d-b14e-9b3f5903b754

> FDA 483 for Les Produits Chimiques B.G.R., Inc. on February 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Les Produits Chimiques B.G.R., Inc.
- Inspection Date: 2025-02-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Les Produits Chimiques B.G.R., Inc., an API manufacturer in Pointe-Claire, revealed significant deficiencies in their quality systems. Observations included a failure to qualify manufacturing equipment, incomplete method verification studies for analytical testing, and an inadequate investigation into an out-of-specification raw material result. These issues indicate a lack of robust controls over API production and quality assurance.

## Related Documents

- [483 - 2017-09-25](https://www.globalkeysolutions.net/records/483/les-produits-chimiques-bgr-inc/2745b568-ab9d-4ade-90eb-d2cae54de609)
- [483 - 2019-01-07](https://www.globalkeysolutions.net/records/483/les-produits-chimiques-bgr-inc/c9906958-61b5-4f43-895b-7695fabf2acd)

## Related Officers

- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Soyinka S. Eneng](https://www.globalkeysolutions.net/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)

Company: https://www.globalkeysolutions.net/companies/les-produits-chimiques-bgr-inc/348f9540-7743-4466-b340-676434a19914

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