FDA Inspection 875801 — Dean and Jean Mikalunas
The FDA completed an inspection of Dean and Jean Mikalunas on April 21, 2014 in Sherburne, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 21, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sherburne, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1389 | 21 CFR 530.11(a) | Withdrawal period |
| 4093 | 21 CFR 530.11(d) | ELDU - producer causes Illegal drug residue |
| 4185 | FDCA 402(a)(4) | Record keeping |