FDA Inspection
Cape Cod HospitalCape Cod Hospital – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Cape Cod Hospital, with an inspection on February 15, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ec234e82-9b4c-4a17-b364-8bfa4796a450
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079428
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 610.41Donor Deferral
- 21 CFR 630.10(f)(6)(ii)Physical Assessment Determination - Skin Examination
- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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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 |
| 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 |
| August 14, 2012 | VAI | 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 997068 - 2016-12-29
- FDA Inspection 900700 - 2014-10-23
- FDA Inspection 795606 - 2012-08-14
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