FDA Inspection 956002 — CCT Critical Care Technologies, S.R.L.
The FDA completed an inspection of CCT Critical Care Technologies, S.R.L. on Dec 9, 2015 in Haina, San Cristobal. 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
- Dec 9, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Haina, San Cristobal (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |