FDA Inspection
Montrose Memorial Hospital Blood BankMontrose Memorial Hospital Blood Bank – FDA Inspection, Sep 17, 2010
Record Details
This FDA Inspection record concerns Montrose Memorial Hospital Blood Bank, with an inspection on September 17, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 17, 2010
- Product Type
- Biologics
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ID · 140e9e9d-5c62-4893-adc5-f3b3e4c3e9d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680990
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.170(b)Adverse reaction - fatality
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 640.3(b)(6)Qualifications of donor - disease transmissible by blood
- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 606.40(a)(6)Provide space for quarantine of unsuitable for use items
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 600.12(a)Maintenance - tracing
- 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 |
| August 3, 2012 | VAI | 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 794753 - 2012-08-03
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