FDA Inspection 1064635 — Western/Scott Fetzer Company
The FDA completed an inspection of Western/Scott Fetzer Company on August 29, 2018 in Westlake, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 29, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westlake, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |