FDA Inspection
Carter BloodCare - TylerCarter BloodCare - Tyler – FDA Inspection, Jun 1, 2016
Record Details
This FDA Inspection record concerns Carter BloodCare - Tyler, with an inspection on June 1, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carter BloodCare - Tyler
- Inspection Date
- June 1, 2016
- Product Type
- Biologics
View Company Profile
ID · ce943196-1cb0-49c1-a00d-65431596f973
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974966
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Carter BloodCare - Tyler
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Dallas District Office | |
| June 16, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 2, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 20, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Carter BloodCare - Tyler
- FDA Inspection 1264020 - 2025-03-07
- FDA Inspection 1173367 - 2022-06-16
- FDA Inspection 1041185 - 2018-02-02
- FDA Inspection 883573 - 2014-06-06
- FDA Inspection 764424 - 2012-01-20
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