FDA Inspection
Med Awareness dba Genesis Tissue ServicesMed Awareness dba Genesis Tissue Services – FDA Inspection, Sep 25, 2014
Record Details
This FDA Inspection record concerns Med Awareness dba Genesis Tissue Services, with an inspection on September 25, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 25, 2014
- Product Type
- Biologics
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ID · efde31b0-bd89-46c6-92e6-1fb43d1ae917
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 896582
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.80(d)(2)Plasma diluted test specimens
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.270(a)Records maintained concurrently
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