1066756
Genecell International, LLC — FEI 3008369088
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |