FDA Inspection
Good Samaritan HospitalGood Samaritan Hospital – FDA Inspection, Sep 3, 2009
Record Details
This FDA Inspection record concerns Good Samaritan Hospital, with an inspection on September 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Good Samaritan Hospital
- Inspection Date
- September 3, 2009
- Product Type
- Biologics
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ID · 5f7122ff-cd13-4e3a-862e-3a4aee18a148
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 604485
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 606.100(b)(21)Donor notification
- 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 |
| February 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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