Advamedica, Inc. – FDA Inspection, Dec 5, 2024

Record Details

This FDA Inspection record concerns Advamedica, Inc., with an inspection on December 5, 2024, issued by the New England District Office, covering medical devices & rad health.

Company: Advamedica, Inc.
Inspection Date: December 5, 2024
Product Type: Medical Devices & Rad Health
Office: New England District Office
Person: James P. Finn (Company Rep)

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ID · 5cda02ae-1f43-4c61-8b18-2613a2502e9c

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1255819
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures

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FDA Inspection

Advamedica, Inc.December 5, 2024