FDA Inspection
Magnamed Tecnologia Medica S/AMagnamed Tecnologia Medica S/A – FDA Inspection, Apr 10, 2025
Record Details
This FDA Inspection record concerns Magnamed Tecnologia Medica S/A, with an inspection on April 10, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 10, 2025
- Product Type
- Medical Devices & Rad Health
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ID · f8422715-1083-443a-8b4a-07c84f46818f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 801.20(a)Label to bear a unique device identifier
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