FDA Inspection 657853 — Zoe Medical Incorporated
The FDA completed an inspection of Zoe Medical Incorporated on April 20, 2010 in Topsfield, MA. 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
- April 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Topsfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |