FDA Inspection 820206 — ARUP Laboratories Inc.
The FDA completed an inspection of ARUP Laboratories Inc. on February 22, 2013 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 22, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |