FDA Inspection
Montrose Memorial Hospital Blood BankMontrose Memorial Hospital Blood Bank – FDA Inspection, Aug 3, 2012
Record Details
This FDA Inspection record concerns Montrose Memorial Hospital Blood Bank, with an inspection on August 3, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 3, 2012
- Product Type
- Biologics
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ID · 5b8b86cb-6f8e-49b8-a1cb-7486cfd12943
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794753
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 640.3(b)(6)Qualifications of donor - disease transmissible by blood
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood
- 21 CFR 606.100(b)(2)Donor qualifying tests & measurements
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Montrose Memorial Hospital Blood Bank
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 17, 2010 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Montrose Memorial Hospital Blood Bank
- FDA Inspection 1010952 - 2017-05-04
- FDA Inspection 915301 - 2015-02-11
- FDA Inspection 680990 - 2010-09-17
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