615235
Pure Source, LLC — FEI 3002754162
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |