FDA Inspection
ITXM Clinical Services, Washington Hospital SiteITXM Clinical Services, Washington Hospital Site – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns ITXM Clinical Services, Washington Hospital Site, with an inspection on October 26, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 26, 2016
- Product Type
- Biologics
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ID · 5ffb7a5c-91f6-418e-b1a5-0f77ecb540e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992486
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of ITXM Clinical Services, Washington Hospital Site
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 3, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ITXM Clinical Services, Washington Hospital Site
- FDA Inspection 900495 - 2014-10-21
- FDA Inspection 806869 - 2012-11-14
- FDA Inspection 697791 - 2010-11-03
- FDA Inspection 559741 - 2009-02-04
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