FDA Inspection
Teka Portugal S.A.Teka Portugal S.A. – FDA Inspection, Nov 11, 2022
Record Details
This FDA Inspection record concerns Teka Portugal S.A., with an inspection on November 11, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Teka Portugal S.A.
- Inspection Date
- November 11, 2022
- Product Type
- Devices
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ID · 2a3dabe6-6567-45bd-8378-e8e22a173784
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190353
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
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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Other FDA inspections of Teka Portugal S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2018 | 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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