FDA Inspection
Governor Juan F. Luis Hospital & Medical CenterGovernor Juan F. Luis Hospital & Medical Center – FDA Inspection, Sep 1, 2011
Record Details
This FDA Inspection record concerns Governor Juan F. Luis Hospital & Medical Center, with an inspection on September 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 1, 2011
- Product Type
- Biologics
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ID · b1212684-2ea1-4a67-8018-c750977081ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742796
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Governor Juan F. Luis Hospital & Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 |
| June 9, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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