ITR Laboratories Canada Inc. – FDA Inspection, May 19, 2023

Record Details

This FDA Inspection record concerns ITR Laboratories Canada Inc., with an inspection on May 19, 2023, issued by the Office of Inspections and Investigations.

Company: ITR Laboratories Canada Inc.
Inspection Date: May 19, 2023
Office: Office of Inspections and Investigations
Person: Jonathan R. Campos (Issuing Officer)

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ID · f77897c3-84e6-4122-85ec-82b7baff270c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1205713
FDA center: Human Drugs
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 58.33(a)Study director: follow study protocol
21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs

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FDA Inspection

ITR Laboratories Canada Inc.May 19, 2023