FDA Inspection
Governor Juan F. Luis Hospital & Medical CenterGovernor Juan F. Luis Hospital & Medical Center – FDA Inspection, Dec 7, 2016
Record Details
This FDA Inspection record concerns Governor Juan F. Luis Hospital & Medical Center, with an inspection on December 7, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 7, 2016
- Product Type
- Biologics
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ID · 9fcdd39f-10f7-49cc-befd-573311673620
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997259
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
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Other FDA inspections of Governor Juan F. Luis Hospital & Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 26, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 9, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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