1174999
Kimera Labs Inc — FEI 3011069063
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 9447 | 21 CFR 610.18(b) | Identity - periodic testing |