FDA Inspection 769932 — 3T Medical Systems, LLC
The FDA completed an inspection of 3T Medical Systems, LLC on February 17, 2012 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |