FDA Inspection
Carter BloodCareCarter BloodCare – FDA Inspection, Mar 17, 2014
Record Details
This FDA Inspection record concerns Carter BloodCare, with an inspection on March 17, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carter BloodCare
- Inspection Date
- March 17, 2014
- Product Type
- Biologics
View Company Profile
ID · c8eeb1fc-8e1d-42e0-a8a6-76e1186ddb51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871589
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 600.11(b)Equipment
- 21 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carter BloodCare
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | NAI | Center for Biologics Evaluation and Research | |
| January 11, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 2, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Carter BloodCare
- FDA Inspection 1272556 - 2025-06-05
- FDA Inspection 1227222 - 2024-01-11
- FDA Inspection 1088131 - 2019-04-05
- FDA Inspection 1029042 - 2017-08-02
- FDA Inspection 775769 - 2012-04-05
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