1020034
SUCO, Inc. — FEI 3001701624
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silver Spring, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |