FDA Inspection 991571 — Pace Analytical Life Sciences
The FDA completed an inspection of Pace Analytical Life Sciences on October 31, 2016 in Salem, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 31, 2016
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |