Jeffrey M. Kaplan, M.D. – FDA Inspection, Sep 20, 2024

Record Details

This FDA Inspection record concerns Jeffrey M. Kaplan, M.D., with an inspection on September 20, 2024, issued by the Kansas City District Office, covering human drugs.

Company: Jeffrey M. Kaplan, M.D.
Inspection Date: September 20, 2024
Product Type: Human Drugs
Office: Kansas City District Office
Person: Karen M. Montgomery (Company Rep)

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ID · d5bfe8a2-b8f4-4bea-b070-4708fcf5d82e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1249701
FDA center: Human Drugs
Project area: Bioresearch Monitoring: Human Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 50.55(e)(2)Two parents' permission: studies under Parts 50.53 - 50.54
21 CFR 312.60FD-1572, protocol compliance
21 CFR 50.55(f)Documentation of permission by parents or guardian
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Jeffrey M. Kaplan, M.D.September 20, 2024