FDA Inspection 885213 — MaxPax, LLC
The FDA completed an inspection of MaxPax, LLC on July 11, 2014 in Elkhorn, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Elkhorn, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |