FDA Inspection
ARUP Laboratories Inc.ARUP Laboratories Inc. – FDA Inspection, Feb 22, 2013
Record Details
This FDA Inspection record concerns ARUP Laboratories Inc., with an inspection on February 22, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ARUP Laboratories Inc.
- Inspection Date
- February 22, 2013
- Product Type
- Biologics
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ID · e3250e06-459d-4431-ba0d-e2e3b1836b6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820206
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65Safe, sanitary, orderly storage
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ARUP Laboratories Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 14, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 2, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ARUP Laboratories Inc.
- FDA Inspection 1244030 - 2024-06-13
- FDA Inspection 1087820 - 2019-03-14
- FDA Inspection 998808 - 2016-12-02
- FDA Inspection 914102 - 2015-02-13
- FDA Inspection 756124 - 2011-11-18
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