FDA Inspection
Cooley Dickinson Hospital, BbCooley Dickinson Hospital, Bb – FDA Inspection, Jul 13, 2009
Record Details
This FDA Inspection record concerns Cooley Dickinson Hospital, Bb, with an inspection on July 13, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 13, 2009
- Product Type
- Biologics
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ID · 96a757a2-6d09-46f5-aa95-ef4c757d99d8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 596162
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 610.41Donor Deferral
- 21 CFR 606.160(b)Required records
- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 610.40(h)Shipment/use of reactive units, units from deferred donors
- 21 CFR 211.68(b)input/output verification
- 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 Cooley Dickinson Hospital, Bb
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Cooley Dickinson Hospital, Bb
- FDA Inspection 649945 - 2010-01-26
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