FDA Inspection 1050401 — Teka Portugal S.A.
The FDA completed an inspection of Teka Portugal S.A. on Apr 27, 2018 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
- Apr 27, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Ilhavo (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 5117 | 21 CFR 1030.10(c)(2)(vi) | Means to monitor interlocks |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |