Sukit Christopher Malaisrie, M.D. – FDA Inspection, Sep 4, 2019

Record Details

This FDA Inspection record concerns Sukit Christopher Malaisrie, M.D., with an inspection on September 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Sukit Christopher Malaisrie, M.D.
Inspection Date: September 4, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Jeanne J. Thai (Company Rep)

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ID · a46c5994-3ce4-41cf-b0f3-6f74396d3c3c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1101197
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
21 CFR 812.100Investigator lack of informed consent

Full citation text and observation details available on the Dashboard.

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FDA Inspection

Sukit Christopher Malaisrie, M.D.September 4, 2019