FDA Inspection 1036549 — Paradox, Inc
The FDA completed an inspection of Paradox, Inc on Dec 27, 2017 in Saint Joseph, 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 27, 2017
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Joseph, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |