ElectroMedics, Inc. – FDA Inspection, Mar 12, 2018

Record Details

This FDA Inspection record concerns ElectroMedics, Inc., with an inspection on March 12, 2018, issued by the New Jersey District Office, covering medical devices & rad health.

Company: ElectroMedics, Inc.
Inspection Date: March 12, 2018
Product Type: Medical Devices & Rad Health
Office: New Jersey District Office
People: David H. Smith (Issuing Officer)
William R. Chang (Issuing Officer)

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ID · ead785f6-034e-46e8-8b6e-909fdd69f0f9

Inspection Facts

Inspection number: 1043958
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.20(e)Quality System Procedures
21 CFR 820.30(j)Design history file

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FDA Inspection

ElectroMedics, Inc.March 12, 2018