FDA Inspection 1058841 - PolarityTE, Inc - July 13, 2018

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Record Details

This FDA Inspection record concerns PolarityTE, Inc, with an inspection on July 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: PolarityTE, Inc
Inspection Date: July 13, 2018
Product Type: Biologics
Office: Center for Biologics Evaluation and Research

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ID · 2386eca8-71eb-44ea-ac72-c127c7c719e4

Violation Codes8

21 CFR 211.100(a)21 CFR 211.160(a)21 CFR 211.166(a)21 CFR 211.22(a)21 CFR 211.42(a)21 CFR 211.42(c)(10)(iv)21 CFR 211.42(c)(10)(v)21 CFR 211.42(c)(5)

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