FDA Inspection 614642 — Kesair Technologies, LLC
The FDA completed an inspection of Kesair Technologies, LLC on Jul 15, 2009 in Kennesaw, GA. 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
- Jul 15, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |