FDA Inspection
Community Blood Bank of Erie CountyCommunity Blood Bank of Erie County – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Community Blood Bank of Erie County, with an inspection on September 8, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6b6cd3f1-baad-4708-a294-74d7e5a2199c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024516
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Community Blood Bank of Erie County
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 10, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 26, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 6, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Community Blood Bank of Erie County
- FDA Inspection 1249780 - 2024-08-23
- FDA Inspection 930034 - 2015-06-10
- FDA Inspection 829171 - 2013-04-26
- FDA Inspection 739272 - 2011-08-25
- FDA Inspection 615395 - 2009-08-06
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