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FDA Inspection
•Fermatex Vascular Technologies•June 24, 2025

Fermatex Vascular Technologies – FDA Inspection, Jun 24, 2025

Record Details

This FDA Inspection record concerns Fermatex Vascular Technologies, with an inspection on June 24, 2025, issued by the New Jersey District Office, covering medical devices & rad health.

Company
Fermatex Vascular Technologies
Inspection Date
June 24, 2025
Product Type
Medical Devices & Rad Health
Office
New Jersey District Office
Person
  • Frank J. Marciniak (Issuing Officer)
View Company Profile

ID · 6cd8d154-0301-48f5-900f-e8bdd8af2490

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1274466
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
  3. 21 CFR 820.184DHR content

Full citation text and observation details available on the Dashboard.

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