FDA Inspection 663119 — Western/Scott Fetzer Company
The FDA completed an inspection of Western/Scott Fetzer Company on May 27, 2010 in Westlake, 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
- May 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westlake, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3837 | 21 CFR 820.25(b) | Training records |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |