FDA Inspection 1135699 — Utah Cord Bank LLC
The FDA completed an inspection of Utah Cord Bank LLC on February 11, 2021 in Sandy, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 19 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 11, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sandy, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |
| 15023 | 21 CFR 1271.270(b) | Management system, other records |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |