FDA Inspection 838112 — Contech Medical, Inc.
The FDA completed an inspection of Contech Medical, Inc. on June 10, 2013 in Providence, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |