FDA Inspection
Electrolux Professional S.p.A.Electrolux Professional S.p.A. – FDA Inspection, May 8, 2025
Record Details
This FDA Inspection record concerns Electrolux Professional S.p.A., with an inspection on May 8, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 8, 2025
- Product Type
- Medical Devices & Rad Health
- People
- Fouad Attioui (Issuing Officer)
- Gregory M. Bessette (Issuing Officer)
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ID · 0fa008d9-9699-4388-85ff-7a1cd00498cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269854
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act (RCHSA) Authority
- Outcome
- Form 483 issued
FDA Citations
2- 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
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