FDA Inspection 1015375 — Preserve Inc.
The FDA completed an inspection of Preserve Inc. on June 22, 2017 in Turlock, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Turlock, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |