1120516
One Umbilical Cord Lab, Inc. — FEI 3013913163
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 12, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Richardson, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 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 |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |