Vivek Reddy, M.D. – FDA Inspection, Mar 7, 2019

Record Details

This FDA Inspection record concerns Vivek Reddy, M.D., with an inspection on March 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Vivek Reddy, M.D.
Inspection Date: March 7, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Karen L. Kosar (FDA Associated Person)

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ID · 5e875b75-27f2-4db5-ba86-74207e6a2a79

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1081723
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
21 CFR 812.43(c)No investigator agreement

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FDA Inspection

Vivek Reddy, M.D.March 7, 2019