FDA Inspection
MedCore Biologix, LLCMedCore Biologix, LLC – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns MedCore Biologix, LLC, with an inspection on October 18, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 95453dd9-b85d-4add-bc4f-6cd1a2c13403
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069477
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
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