Spineway – FDA Inspection, Jul 18, 2019

Record Details

This FDA Inspection record concerns Spineway, with an inspection on July 18, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Spineway
Inspection Date: July 18, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Thai T. Duong (Issuing Officer)

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ID · d6b60c51-d977-4554-b191-da32465248af

Inspection Facts

Inspection number: 1098120
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.100(a)Lack of or inadequate procedures

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FDA Inspection

SpinewayJuly 18, 2019