Biometrix Ltd. – FDA Inspection, Aug 15, 2019

Record Details

This FDA Inspection record concerns Biometrix Ltd., with an inspection on August 15, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Biometrix Ltd.
Inspection Date: August 15, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Andrew J. Garufi (Issuing Officer)

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ID · b3e232ed-0eb4-4689-b1a9-0ce963d6706b

Inspection Facts

Inspection number: 1100114
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(e)Design review - documentation
21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

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FDA Inspection

Biometrix Ltd.August 15, 2019