FDA Inspection 814003 — MaxPax, LLC
The FDA completed an inspection of MaxPax, LLC on January 14, 2013 in Elkhorn, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Elkhorn, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 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. |