FDA Inspection 656213 — Dixtal Medical, Inc.
The FDA completed an inspection of Dixtal Medical, Inc. on Apr 13, 2010 in Wallingford, CT. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 13, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wallingford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |