727928
ARUP Laboratories, Inc. — FEI 1720911
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 20, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sandy, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 251 | 21 CFR 640.25(b) | Quality control |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9225 | 21 CFR 606.171 | Biological product deviation report |