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FDA Inspection
•Clarus Safety Consulting, LLC•August 2, 2024

Clarus Safety Consulting, LLC – FDA Inspection, Aug 2, 2024

Record Details

This FDA Inspection record concerns Clarus Safety Consulting, LLC, with an inspection on August 2, 2024, covering devices.

Company
Clarus Safety Consulting, LLC
Inspection Date
August 2, 2024
Product Type
Devices
Person
  • Colleen E. Burke (Company Rep)
View Company Profile

ID · ae7ad405-2deb-461c-8524-d59a44192599

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1245325
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
  2. 21 CFR 56.108(a)(1)Initial and continuing reviews
  3. 21 CFR 56.110(b)Research not eligible for expedited review

Full citation text and observation details available on the Dashboard.

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