1165854
Invitrx Therapeutics Inc. — FEI 3015252551
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4321 | 21 CFR 211.101(b) | Identification of new containers |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |