FDA Inspection 987532 — ChemRite CoPac LLC
The FDA completed an inspection of ChemRite CoPac LLC on July 15, 2016 in Lannon, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 15, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Lannon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |