1102160
Invitrx Therapeutics — FEI 3015766791
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 18, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |