1246548
Chara Biologics, Inc. — FEI 3015265204
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 16, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12480 | 21 CFR 1271.370(c)(1) | Name, address on label or documentation |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |