# FDA 483 - PF Soins de Sante SRI - October 27, 2023

Source: https://www.globalkeysolutions.net/records/483/pf-soins-de-sante-sri/6558c130-868a-4b26-9c23-4431f8e69d59

> FDA 483 for PF Soins de Sante SRI on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PF Soins de Sante SRI
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of PF Consumer Healthcare Canada ULC in Saint-Laurent, a drug manufacturer, revealed significant deficiencies in its quality control unit. Observations included contaminated manufacturing environments with rust, mold, and dust in ceiling grids, potentially compromising product safety. Additionally, the firm failed to thoroughly investigate multiple customer complaints regarding product quality and adverse events, as well as an out-of-specification result.

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/pf-soins-de-sante-sri/9e60bbed-a0ce-4353-ae08-a599608d5bd4

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