Namsa – FDA Inspection, Nov 17, 2017

Record Details

This FDA Inspection record concerns Namsa, with an inspection on November 17, 2017, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: Namsa
Inspection Date: November 17, 2017
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office
Person: Nicole C. Victoria (Company Rep)

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ID · 009e0f4d-9596-425e-b482-ce3ddab8ea10

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1031584
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 58.31(f)Management: personnel understand their functions
21 CFR 58.33(e)Study director: follow GLP regulations
21 CFR 58.35(a)QAU: monitor facilities, etc.

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FDA Inspection

NamsaNovember 17, 2017