FDA Inspection
Community Blood Bank of Erie CountyCommunity Blood Bank of Erie County – FDA Inspection, Jun 10, 2015
Record Details
This FDA Inspection record concerns Community Blood Bank of Erie County, with an inspection on June 10, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 10, 2015
- Product Type
- Biologics
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ID · 8eee931d-7e40-4101-afb7-0ced0f2fdad4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930034
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 211.68(a)Written calibration / inspection records not kept
Full citation text and observation details available on the Dashboard.
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 |
| 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 1024516 - 2017-09-08
- FDA Inspection 829171 - 2013-04-26
- FDA Inspection 739272 - 2011-08-25
- FDA Inspection 615395 - 2009-08-06
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