FDA Inspection
Quest DiagnosticsQuest Diagnostics – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns Quest Diagnostics, with an inspection on August 25, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Quest Diagnostics
- Inspection Date
- August 25, 2016
- Product Type
- Biologics
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ID · 1117ba6a-b38e-49a9-8c17-e29aa34fdbfa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983437
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Quest Diagnostics
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 18, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 22, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Quest Diagnostics
- FDA Inspection 1245312 - 2024-07-30
- FDA Inspection 1069321 - 2018-09-13
- FDA Inspection 889102 - 2014-07-28
- FDA Inspection 799707 - 2012-09-18
- FDA Inspection 681842 - 2010-09-22
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