FDA Inspection 761167 — Electro Cap International Inc
The FDA completed an inspection of Electro Cap International Inc on November 29, 2011 in Eaton, OH. 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
- November 29, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eaton, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |