Shefabone Inc. – FDA Inspection, Nov 2, 2018

Record Details

This FDA Inspection record concerns Shefabone Inc., with an inspection on November 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Shefabone Inc.
Inspection Date: November 2, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Gamal A. Norton (Issuing Officer)

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ID · e64ab4f3-d36d-4538-8c09-0b37b14c6221

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1071019
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 820.80(b)Lack of or inadequate receiving acceptance procedures

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FDA Inspection

Shefabone Inc.November 2, 2018