FDA Inspection
Carter BloodCareCarter BloodCare – FDA Inspection, Jul 27, 2011
Record Details
This FDA Inspection record concerns Carter BloodCare, with an inspection on July 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carter BloodCare
- Inspection Date
- July 27, 2011
- Product Type
- Biologics
View Company Profile
ID · 496721d8-2462-46d6-8502-3ae33bf60da4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 736481
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 640.3(a)Donor suitability not performed on day of collection
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 640.56(d)Potency level - corrective action
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| December 6, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 29, 2013 | NAI | 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 1033975 - 2017-12-06
- FDA Inspection 846717 - 2013-08-29
- FDA Inspection 604811 - 2009-08-17
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