FDA Inspection
St Joseph's University Medical Center - Blood BankSt Joseph's University Medical Center - Blood Bank – FDA Inspection, Apr 16, 2012
Record Details
This FDA Inspection record concerns St Joseph's University Medical Center - Blood Bank, with an inspection on April 16, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 16, 2012
- Product Type
- Biologics
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ID · 08412dd6-23a4-4743-aff8-840af89a656f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777003
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.140(a)Establishment of spec., standards, and test procedures
- 21 CFR 606.20(c)Exclusion of certain persons
- 21 CFR 606.60(a)Maintain and clean equipment
- 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 St Joseph's University Medical Center - Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 11, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 17, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 5, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St Joseph's University Medical Center - Blood Bank
- FDA Inspection 1163483 - 2022-02-11
- FDA Inspection 1048440 - 2018-04-11
- FDA Inspection 953275 - 2015-12-10
- FDA Inspection 863007 - 2014-01-17
- FDA Inspection 660288 - 2010-05-05
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