FDA Inspection
Medcore Biologix LLCMedcore Biologix LLC – FDA Inspection, Nov 19, 2019
Record Details
This FDA Inspection record concerns Medcore Biologix LLC, with an inspection on November 19, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Medcore Biologix LLC
- Inspection Date
- November 19, 2019
- Product Type
- Biologics
View Company Profile
ID · 0400ddab-cc8d-421d-9def-dde77ef200e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110608
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
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