FDA Inspection 971375 — ChemRite CoPac LLC
The FDA completed an inspection of ChemRite CoPac LLC on March 24, 2016 in Lannon, 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Lannon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |