1070430
U.S. Continental Marketing, Inc. — FEI 3005519645
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 30, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |