FDA Inspection
Cape Cod HospitalCape Cod Hospital – FDA Inspection, Aug 14, 2012
Record Details
This FDA Inspection record concerns Cape Cod Hospital, with an inspection on August 14, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Cape Cod Hospital
- Inspection Date
- August 14, 2012
- Product Type
- Biologics
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ID · 29c56d2a-2003-412e-9b60-5e47fd92eceb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795606
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 610.41Donor Deferral
- 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 Cape Cod Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 15, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 23, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Cape Cod Hospital
- FDA Inspection 1249436 - 2024-09-10
- FDA Inspection 1157650 - 2021-11-05
- FDA Inspection 1079428 - 2019-02-15
- FDA Inspection 997068 - 2016-12-29
- FDA Inspection 900700 - 2014-10-23
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