FDA Inspection
Good Samaritan HospitalGood Samaritan Hospital – FDA Inspection, Feb 1, 2011
Record Details
This FDA Inspection record concerns Good Samaritan Hospital, with an inspection on February 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Good Samaritan Hospital
- Inspection Date
- February 1, 2011
- Product Type
- Biologics
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ID · 84cbdea0-4d10-4052-b492-35bd03cc3251
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706969
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Good Samaritan Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 13, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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