Imediplus Inc. – FDA Inspection, Feb 22, 2019

Record Details

This FDA Inspection record concerns Imediplus Inc., with an inspection on February 22, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Imediplus Inc.
Inspection Date: February 22, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Kwong P. Lee (Company Rep)

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ID · ac0f4e65-5118-4db0-8e01-f3032807242d

Inspection Facts

Inspection number: 1082530
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(g)Design validation - simulated testing
21 CFR 820.40(b)Change records, content

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FDA Inspection

Imediplus Inc.February 22, 2019