FDA Inspection
SARMED SRLSARMED SRL – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns SARMED SRL, with an inspection on May 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93939361-273f-4ee6-8f3d-5dca48c154b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of SARMED SRL
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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