FDA Inspection 1049182 — Natural Awe LLC., dba Hobe Labs
The FDA completed an inspection of Natural Awe LLC., dba Hobe Labs on April 20, 2018 in Tempe, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |