FDA Inspection
WHIRLPOOL EMEA SPAWHIRLPOOL EMEA SPA – FDA Inspection, Dec 15, 2023
Record Details
This FDA Inspection record concerns WHIRLPOOL EMEA SPA, with an inspection on December 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3bf32753-57e5-41f3-894a-e467a3b42764
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225054
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1030.10(c)(3)(iv)Door position
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 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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