FDA Inspection 949228 — Best Sanitizers Inc
The FDA completed an inspection of Best Sanitizers Inc on Oct 16, 2015 in Walton, KY. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 16, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Walton, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |