FDA Inspection 951951 — C&W Swiss Inc
The FDA completed an inspection of C&W Swiss Inc on November 19, 2015 in Englewood, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |