FDA Inspection
MedEx Surgical, LLPMedEx Surgical, LLP – FDA Inspection, Oct 25, 2017
Record Details
This FDA Inspection record concerns MedEx Surgical, LLP, with an inspection on October 25, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 1776a2be-531f-4803-ac59-81a7178f4237
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029747
- 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 1271.260(e)Storage temperatures recorded, maintained
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