FDA Inspection 1092042 — ClearH2O Inc
The FDA completed an inspection of ClearH2O Inc on June 6, 2019 in Westbrook, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Westbrook, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |