1096665
Stream2Sea, LLC — FEI 3015234524
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bowling Green, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |