FDA Inspection
Teka Portugal S.A.Teka Portugal S.A. – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns Teka Portugal S.A., with an inspection on April 27, 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 · a3759183-1861-4a42-b46e-548d45556d75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050401
- 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 Teka Portugal S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 11, 2022 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 6, 2016 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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