FDA Inspection 905408 — Big Gain, Inc.
The FDA completed an inspection of Big Gain, Inc. on December 3, 2014 in Mankato, MN. 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
- December 3, 2014
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Mankato, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1466 | 21 CFR 225.20(b)(2) | Maintain building in clean and orderly condition |
| 1535 | 21 CFR 225.42(b)(2) | Storage of packaged drugs |
| 1575 | 21 CFR 225.42(b)(4) | Integrity and identity |
| 1638 | 21 CFR 225.42(b)(5) | Elements of receipt record |
| 1811 | 21 CFR 225.58(b)(1) | Three assays per year |