FDA Inspection 756820 — ChemRite CoPac LLC
The FDA completed an inspection of ChemRite CoPac LLC on November 21, 2011 in Lannon, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lannon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |