Kimberly L. Wagner, M.D. – FDA Inspection, Sep 13, 2024

Record Details

This FDA Inspection record concerns Kimberly L. Wagner, M.D., with an inspection on September 13, 2024, issued by the Denver District Office, covering human drugs.

Company: Kimberly L. Wagner, M.D.
Inspection Date: September 13, 2024
Product Type: Human Drugs
Office: Denver District Office
Person: Courtney R. Bratina (Company Rep)

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ID · f78208cb-1330-41b0-973b-014a83862df0

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1249381
FDA center: Human Drugs
Project area: Bioresearch Monitoring: Human Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.60FD-1572, protocol compliance

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FDA Inspection

Kimberly L. Wagner, M.D.September 13, 2024