FDA Inspection
Mount Auburn Hospital Blood BankMount Auburn Hospital Blood Bank – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Mount Auburn Hospital Blood Bank, with an inspection on September 29, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 95dec953-a842-4ded-b1db-5783ed51ae8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028255
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 630.10(d)(2)Donation interval
- 21 CFR 630.30(b)(2)Unsuitable donation - defer testing
- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Mount Auburn Hospital Blood Bank
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 16, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 27, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mount Auburn Hospital Blood Bank
- FDA Inspection 938897 - 2015-08-05
- FDA Inspection 814245 - 2013-01-16
- FDA Inspection 732684 - 2011-06-27
- FDA Inspection 668348 - 2010-06-29
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