FDA Inspection
Community Blood Bank of Erie CountyCommunity Blood Bank of Erie County – FDA Inspection, Apr 26, 2013
Record Details
This FDA Inspection record concerns Community Blood Bank of Erie County, with an inspection on April 26, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 26, 2013
- Product Type
- Biologics
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ID · 214b2d51-77eb-4bdb-ab19-a1260ed64769
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829171
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.5(e)Testing - inspection
- 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 |
| September 8, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 10, 2015 | 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 1024516 - 2017-09-08
- FDA Inspection 930034 - 2015-06-10
- FDA Inspection 739272 - 2011-08-25
- FDA Inspection 615395 - 2009-08-06
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