FDA Inspection
Wyckoff Heights Medical Center Blood BankWyckoff Heights Medical Center Blood Bank – FDA Inspection, Sep 15, 2015
Record Details
This FDA Inspection record concerns Wyckoff Heights Medical Center Blood Bank, with an inspection on September 15, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 15, 2015
- Product Type
- Biologics
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ID · b1d5f2f1-b555-48e3-8625-0351e66e3ba1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941829
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.40Suitable size, construction, etc.
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Wyckoff Heights Medical Center Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 22, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 3, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Wyckoff Heights Medical Center Blood Bank
- FDA Inspection 1074506 - 2018-11-29
- FDA Inspection 1006428 - 2017-03-22
- FDA Inspection 861530 - 2014-01-10
- FDA Inspection 790694 - 2012-07-03
- FDA Inspection 626058 - 2009-11-18
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