FDA Inspection 729104 — Oralx Corporation
The FDA completed an inspection of Oralx Corporation on June 6, 2011 in Ogden, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |