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

FDA Inspection 1058841 for PolarityTE, Inc on July 13, 2018. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1058841 for PolarityTE, Inc on July 13, 2018. Classification: Voluntary Action Indicated (VAI).

Violation Codes

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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Record Information

Company

PolarityTE, Inc

Inspection Date

July 13, 2018

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

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

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