FDA Inspection
Welbilt U.K. LtdWelbilt U.K. Ltd – FDA Inspection, Apr 25, 2018
Record Details
This FDA Inspection record concerns Welbilt U.K. Ltd, with an inspection on April 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Gregory M. Bessette (Issuing Officer)
- Michael P. Sweeney (Issuing Officer)
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ID · 9b3d4ea9-0f06-408b-a2d4-0841411ca8e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050400
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1030.10(c)(2)(vi)Means to monitor interlocks
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
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Other FDA inspections of Welbilt U.K. Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2022 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 27, 2016 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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