FDA Inspection
Carter BloodCareCarter BloodCare – FDA Inspection, Dec 6, 2017
Record Details
This FDA Inspection record concerns Carter BloodCare, with an inspection on December 6, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 5b928782-bdfe-46a1-84fb-78e39dcb3cf5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1033975
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.120(a)Notification to and approval from CBER
- 21 CFR 640.4(f)Arm preparation
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Other FDA inspections of Carter BloodCare
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 12, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 29, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 27, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 17, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Carter BloodCare
- FDA Inspection 1217918 - 2023-08-22
- FDA Inspection 1093449 - 2019-04-12
- FDA Inspection 846717 - 2013-08-29
- FDA Inspection 736481 - 2011-07-27
- FDA Inspection 604811 - 2009-08-17
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