FDA WARNING_LETTER - Irvine Stem Cell Treatment Center - September 19, 2015

FDA WARNING_LETTER for Irvine Stem Cell Treatment Center on September 19, 2015. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Irvine Stem Cell Treatment Center on September 19, 2015. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

21 CFR 211.68(a)

21 CFR 1271.10(a)(2)

21 CFR 211.160(b)

21 CFR 211.42(c)(10)(iv)

21 U.S.C. 355(i)

21.U.S.C. 355(a)

21 CFR 1271.290(c)

42 U.S.C. 262(i)

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Record Information

Company

Irvine Stem Cell Treatment Center

Inspection Date

September 19, 2015

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

People

Mary A. Malarkey (Director - - Ex-FDA)

ID: cf1950ed-4bdb-4290-b0ba-6c5c13f9b5e6

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