FDA WARNING_LETTER - Centra Health Inc IRB - September 14, 2009

FDA WARNING_LETTER for Centra Health Inc IRB on September 14, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Centra Health Inc IRB on September 14, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 56.108(c)

21 CFR 56.112

21 CFR 56.109(f)

21 CFR 56.108(b)(1)(2)

21 CFR 56.115(a)(2)

21 CFR 56.108(a)(2)

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Record Information

Company

Centra Health Inc IRB

Inspection Date

September 14, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy A. Ulatowski (Director)

ID: 2095971c-6e4b-4160-9ae4-546f7123b0ef

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