FDA Inspection 682236 — First Priority, Inc.
The FDA completed an inspection of First Priority, Inc. on Sep 29, 2010 in Elgin, IL. 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). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |