FDA Inspection 665318 — Solafeet, Inc.
The FDA completed an inspection of Solafeet, Inc. on May 28, 2010 in Sarasota, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 28, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |