FDA Inspection 1120516 — One Umbilical Cord Lab, Inc.
The FDA completed an inspection of One Umbilical Cord Lab, Inc. on Mar 12, 2020 in Richardson, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 14 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 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 |