483
ITR Laboratories Canada Inc.ITR Laboratories Canada Inc. – FDA 483, May 19, 2023
Record Details
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.
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ID · 107a598b-6399-450d-bc9b-3b576dee424f
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