FDA Inspection
Huron Regional Medical Center Blood BankHuron Regional Medical Center Blood Bank – FDA Inspection, Apr 27, 2011
Record Details
This FDA Inspection record concerns Huron Regional Medical Center Blood Bank, with an inspection on April 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 27, 2011
- Product Type
- Biologics
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ID · 4260eb4c-0cb2-4bd0-9e03-6a8f1cfe7fb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 726085
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.40(a)(2)Provide space for blood withdrawal
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Huron Regional Medical Center Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 10, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Huron Regional Medical Center Blood Bank
- FDA Inspection 1098665 - 2019-07-31
- FDA Inspection 1018715 - 2017-06-14
- FDA Inspection 904775 - 2014-11-05
- FDA Inspection 832724 - 2013-05-10
- FDA Inspection 738314 - 2011-07-20
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