FDA Inspection 1190353 — Teka Portugal S.A.
The FDA completed an inspection of Teka Portugal S.A. on Nov 11, 2022 in Ilhavo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 11, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Ilhavo (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |