FDA Inspection 859569 — Gutman Brothers, Ltd.
The FDA completed an inspection of Gutman Brothers, Ltd. on December 20, 2013 in New Holland, PA. 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
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- New Holland, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4093 | 21 CFR 530.11(d) | ELDU - producer causes Illegal drug residue |
| 4185 | FDCA 402(a)(4) | Record keeping |
| 4186 | FDCA 402(a)(4) | System for administration of drugs |