FDA Inspection
Mercy Hospital Inc. dba Mercy Medical Center Blood BankMercy Hospital Inc. dba Mercy Medical Center Blood Bank – FDA Inspection, Mar 10, 2011
Record Details
This FDA Inspection record concerns Mercy Hospital Inc. dba Mercy Medical Center Blood Bank, with an inspection on March 10, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 10, 2011
- Product Type
- Biologics
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ID · 06218d85-e638-45ea-b33f-3f88c53393c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 714269
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 630.40(a)Notification
- 21 CFR 606.100(b)(20)Donor deferral
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Mercy Hospital Inc. dba Mercy Medical Center Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 12, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mercy Hospital Inc. dba Mercy Medical Center Blood Bank
- FDA Inspection 865783 - 2014-02-26
- FDA Inspection 777181 - 2012-04-12
- FDA Inspection 607025 - 2009-08-21
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