FDA Inspection
Meneghetti Spa Sede LegalMeneghetti Spa Sede Legal – FDA Inspection, Dec 12, 2023
Record Details
This FDA Inspection record concerns Meneghetti Spa Sede Legal, with an inspection on December 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9b2113f8-190a-4b33-83d8-a3f3627e50c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224728
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1030.10(c)(2)(i)One interlock concealed and not operable b y human
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(iv)Door position
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(2)(i)One interlock concealed and not operable b y human
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1030.10(c)(3)(iv)Door position
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Other FDA inspections of Meneghetti Spa Sede Legal
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2025 | VAI | Office of Inspections and Investigations | Radiation Control and Health Safety Act (RCHSA) Authority |
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