FDA Inspection 1177799 — Centro de Construccion de Cardioestimuladores del Uruguay SA
The FDA completed an inspection of Centro de Construccion de Cardioestimuladores del Uruguay SA on August 18, 2022 in Montevideo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Montevideo (Uruguay)
Citations
| ID | CFR | Description |
|---|---|---|
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |