FDA Inspection
Carter BloodCareCarter BloodCare – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Carter BloodCare, with an inspection on October 26, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · cfd68e9f-72fb-4a68-a7a3-23c55cb4626a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070324
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 640.4(h)Storage temperatures after collection
- 21 CFR 630.30(a)(2)Donor health
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 630.10(e)(2)Additional Medical Assessment Factors
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Other FDA inspections of Carter BloodCare
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 21, 2016 | Not classified | Dallas District Office |
Other documents for Carter BloodCare
- FDA Inspection 1247313 - 2024-06-27
- FDA Inspection 996669 - 2016-12-21
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