FDA Inspection
SMEG S.p.A.SMEG S.p.A. – FDA Inspection, May 11, 2023
Record Details
This FDA Inspection record concerns SMEG S.p.A., with an inspection on May 11, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Gregory M. Bessette (Issuing Officer)
- Nassim Ben Makhlouf (Issuing Officer)
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ID · fb32ca6f-977c-4eea-8385-ed83bdaa889c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206032
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(iii)Measurements with tap water container
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1030.10(c)(3)(iii)Water container specs
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1030.10(c)(3)(iii)Measurements with tap water container
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Other FDA inspections of SMEG S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | Not classified | Office of Inspections and Investigations |
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