# FDA 483 - 8046255 Canada Inc. DBA Viatrexx - September 24, 2019

Source: https://www.keypedia.com/records/483/8046255-canada-inc-dba-viatrexx/5a6e4438-346a-48c0-9674-280f370ec9c4

> FDA 483 for 8046255 Canada Inc. DBA Viatrexx on September 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 8046255 Canada Inc. DBA Viatrexx
- Inspection Date: 2019-09-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected 8046255 Canada Inc. DBA Viatrexx, a sterile injectable drug product manufacturer in Beloeil, from September 16-24, 2019. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, laboratory controls, and quality control record-keeping, indicating a severe lack of adherence to cGMP for sterile drug manufacturing. These issues raise serious concerns about the sterility and quality assurance of their injectable drug products.

## Related Documents

- [WARNING_LETTER - 2019-09-24](https://www.keypedia.com/records/warning_letter/8046255-canada-inc-dba-viatrexx/b2e7731a-68ae-4f53-81b3-ef9989e0b51f)

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

Company: https://www.keypedia.com/companies/8046255-canada-inc-dba-viatrexx/e7c9b7da-42e6-409a-ae63-4c42ca69ea4e

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