# FDA 483 - Les Produits Chimiques B.G.R., Inc. - September 25, 2017

Source: https://www.globalkeysolutions.net/records/483/les-produits-chimiques-bgr-inc/2745b568-ab9d-4ade-90eb-d2cae54de609

> FDA 483 for Les Produits Chimiques B.G.R., Inc. on September 25, 2017. 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: 2017-09-25
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: The FDA inspection of Les Produits Chimiques B.G.R., Inc. in Pointe-Claire, Quebec, Canada, revealed significant deficiencies in quality control and manufacturing processes for Active Pharmaceutical Ingredients. Observations included unperformed QC tests reported as passed, inadequate documentation of analytical data and batch records, and a lack of environmental monitoring for retain samples. The firm also failed to ensure proper material sampling, pest control, equipment cleaning validation, and personnel training, indicating a broad lack of adherence to cGMP requirements.

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## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321