FDA Inspection 727674 — Ourvita DBA Ion Labs Inc.
The FDA completed an inspection of Ourvita DBA Ion Labs Inc. on June 3, 2011 in Largo, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 3, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15912 | 21 CFR 111.90(c) | Reprocessed batch - quality control approve |