FDA Inspection 749433 — Regancrest Holsteins Inc.
The FDA completed an inspection of Regancrest Holsteins Inc. on October 13, 2011 in Waukon, IA. 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 13, 2011
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Waukon, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1360 | FDCA 501(a)(5) | Expired drugs administered |
| 4118 | 21 CFR 530.13(b)(3) | Compounding outside of scope of professional practice |
| 4185 | FDCA 402(a)(4) | Record keeping |