Mark Dacey, M.D. – FDA Inspection, Nov 8, 2024

Record Details

This FDA Inspection record concerns Mark Dacey, M.D., with an inspection on November 8, 2024, issued by the Denver District Office, covering human drugs.

Company: Mark Dacey, M.D.
Inspection Date: November 8, 2024
Product Type: Human Drugs
Office: Denver District Office
Person: Theressa B. Smith (Issuing Officer)

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ID · f90b7f0d-ceb1-47dc-8860-8a13d300e1a9

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1253974
FDA center: Human Drugs
Project area: Bioresearch Monitoring: Human Drugs
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 50.20Consent not obtained, exceptions do not apply

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FDA Inspection

Mark Dacey, M.D.November 8, 2024