FDA Inspection
The Blood Connection, Inc.The Blood Connection, Inc. – FDA Inspection, Sep 30, 2013
Record Details
This FDA Inspection record concerns The Blood Connection, Inc., with an inspection on September 30, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- The Blood Connection, Inc.
- Inspection Date
- September 30, 2013
- Product Type
- Biologics
View Company Profile
ID · e66c61f9-1106-4f2a-aa35-8614805e01de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850756
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.160(b)(6)Required records - transfusion reaction and complaints
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of The Blood Connection, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | Not classified | Atlanta District Office | |
| December 2, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 25, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 26, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 25, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for The Blood Connection, Inc.
- FDA Inspection 1254790 - 2025-08-01
- FDA Inspection 1192900 - 2022-12-02
- FDA Inspection 1068240 - 2018-09-25
- FDA Inspection 982571 - 2016-08-26
- FDA Inspection 981781 - 2016-08-25
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