FDA Inspection 732188 — Ana - Tech FA LLC
The FDA completed an inspection of Ana - Tech FA LLC on July 12, 2011 in Monroe, WI. 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
- July 12, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Monroe, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |