1019160
American CryoStem Corporation — FEI 3008307548
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Monmouth Junction, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |