Jennifer W. Leiding M.D. – FDA Inspection, Sep 8, 2023

Record Details

This FDA Inspection record concerns Jennifer W. Leiding M.D., with an inspection on September 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Jennifer W. Leiding M.D.
Inspection Date: September 8, 2023
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
People: Angelica M. Chica (Issuing Officer)
Valerie L Kelesyan (Issuing Officer)

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ID · b0657a19-2491-40ae-a245-161cb4017a41

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1217194
FDA center: Biologics
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60Informed consent
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.64(b)Safety Reports - Non-Serious Events
21 CFR 312.60Informed consent
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.64(b)Safety Reports - Non-Serious Events

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FDA Inspection

Jennifer W. Leiding M.D.September 8, 2023