# ITR Laboratories Canada Inc. – FDA 483, May 19, 2023

Source: https://www.keypedia.com/records/483/itr-laboratories-canada-inc/107a598b-6399-450d-bc9b-3b576dee424f

> FDA 483 for ITR Laboratories Canada Inc. on May 19, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITR Laboratories Canada Inc.
- Inspection Date: 2023-05-19
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of ITR Laboratories Canada Inc., a nonclinical laboratory in Baie-D'Urfe, revealed significant deficiencies in their quality assurance unit's oversight of protocol and SOP deviations, as well as the study director's failure to ensure protocol adherence and proper amendment documentation. These issues indicate a lack of control over critical aspects of study conduct and data integrity.

## Related Officers

- [other](https://www.keypedia.com/people/erin-m-mcdowell/7f3995e6-5596-4b3a-a99b-27d49d4b890e)
- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/itr-laboratories-canada-inc/719e388a-8ec9-4646-85a0-3248a0ef31c7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8