Jeffrey W. Groves, M.D. – FDA Inspection, Apr 4, 2019

Record Details

This FDA Inspection record concerns Jeffrey W. Groves, M.D., with an inspection on April 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Jeffrey W. Groves, M.D.
Inspection Date: April 4, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Ruth A. Williams (Company Rep)
Stephen T. Hansen (Company Rep)
Theressa B. Smith (Issuing Officer)

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ID · b9def0da-c8c7-4126-945d-11ee6c6c2c3f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1085082
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 812.2(b)Abbreviated requirements / non-significant risk study

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FDA Inspection

Jeffrey W. Groves, M.D.April 4, 2019