1073266
Cord for Life, Inc. — FEI 1000525281
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Altamonte Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |