# FDA 483 - E-Z-EM Canada, Inc - October 20, 2023

Source: https://www.globalkeysolutions.net/records/483/e-z-em-canada-inc/a7042e67-c903-48ff-9190-e1afdc0605ea

> FDA 483 for E-Z-EM Canada, Inc on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E-Z-EM Canada, Inc
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: E-Z-EM Canada, Inc., a drug product manufacturer in Anjou, was cited for significant quality control failures during an FDA inspection. Observations included the quality control unit's failure to detect and investigate tank damage that could contaminate drug products, and a failure to thoroughly investigate numerous customer complaints regarding product contamination. These issues indicate a lack of robust quality system procedures and follow-through.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/e-z-em-canada-inc/de31e064-9679-4127-b65f-39ecba03c801

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