FDA Inspection 848620 — The Soule Company
The FDA completed an inspection of The Soule Company on Sep 16, 2013 in Lutz, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lutz, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |