FDA Inspection 980876 — Cirtec Medical Corporation
The FDA completed an inspection of Cirtec Medical Corporation on August 5, 2016 in Enfield, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Enfield, CT (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |