# FDA 483 - Les Produits Chimiques B.G.R., Inc. - January 07, 2019

Source: https://www.globalkeysolutions.net/records/483/les-produits-chimiques-bgr-inc/c9906958-61b5-4f43-895b-7695fabf2acd

> FDA 483 for Les Produits Chimiques B.G.R., Inc. on January 07, 2019. 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: 2019-01-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Les Produits Chimiques B.G.R., Inc. in Pointe-Claire, Quebec, an API manufacturer, revealed significant deficiencies in quality assurance, production, and laboratory controls for (b)(4) USP Powder. The firm was cited for issues including inadequate raw material approval, deficient cleaning validation, lack of sampling plans, and poor documentation in batch records and analytical testing. Many of these observations were repeats from a previous inspection, indicating persistent non-compliance.

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## Related Officers

- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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

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