FDA WARNING_LETTER - Teneo IRB - March 18, 2009

FDA WARNING_LETTER for Teneo IRB on March 18, 2009. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Teneo IRB on March 18, 2009. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 56.115(a)(1)

21 CFR 50

21 CFR 56.120(b)(1)

21 CFR 56.120(b)(2)

21 CFR 56.106

21 CFR 56

21 CFR 56.115(a)(2)

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Record Information

Company

Teneo IRB

Inspection Date

March 18, 2009

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

People

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

ID: cee35e13-b089-493c-989f-f2b7b169a25d

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