FDA Inspection 747729 — Best Sanitizers Inc
The FDA completed an inspection of Best Sanitizers Inc on August 8, 2011 in Walton, KY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 8, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Walton, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |