FDA Inspection
Lowell General Hospital-Saints CampusLowell General Hospital-Saints Campus – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Lowell General Hospital-Saints Campus, with an inspection on February 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 2, 2012
- Product Type
- Biologics
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ID · 07d5b967-e82a-489c-a66d-9f689895c2df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766142
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
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Other FDA inspections of Lowell General Hospital-Saints Campus
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 6, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Lowell General Hospital-Saints Campus
- FDA Inspection 821662 - 2013-03-05
- FDA Inspection 684200 - 2010-10-06
- FDA Inspection 601765 - 2009-07-31
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