FDA Inspection 727928 — ARUP Laboratories, Inc.
The FDA completed an inspection of ARUP Laboratories, Inc. on May 20, 2011 in Sandy, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- 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 |