FDA Inspection 1079798 — AquaScience Technologies & Research Inc.
The FDA completed an inspection of AquaScience Technologies & Research Inc. on Feb 19, 2019 in Richmond, MO. 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Richmond, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4576 | 21 CFR 211.192 | No written record of investigation |