Halifax Biomedical Inc. – FDA Inspection, Apr 6, 2018

Record Details

This FDA Inspection record concerns Halifax Biomedical Inc., with an inspection on April 6, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Halifax Biomedical Inc.
Inspection Date: April 6, 2018
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Jeffrey J. Thibodeau (FDA Associated Person)

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ID · 0056f7aa-659c-4ffa-aebc-cfaff117653b

Inspection Facts

Inspection number: 1047167
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(e)Design review - documentation
21 CFR 820.30(g)Design validation - user needs and intended uses

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FDA Inspection

Halifax Biomedical Inc.April 6, 2018