FDA WARNING_LETTER - TCA Cellular Therapy, LLC - March 31, 2011

FDA WARNING_LETTER for TCA Cellular Therapy, LLC on March 31, 2011. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for TCA Cellular Therapy, LLC on March 31, 2011. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 312.50

21 CFR 1271.75

21 CFR 1271.50(a)

21 CFR 1271.85

21 CFR 312.30

21 CFR 312.42(a)

21 CFR 1271.85(b)(1)

21 CFR 312.20

21 CFR 312.40

21 CFR 1271.80

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Record Information

Company

TCA Cellular Therapy, LLC

Inspection Date

March 31, 2011

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

People

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

ID: dafb299c-fcc7-42c8-a909-e222cd61d5d0

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