FDA WARNING_LETTER - Colorado Histo-Prep - May 10, 2013

FDA WARNING_LETTER for Colorado Histo-Prep on May 10, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Colorado Histo-Prep on May 10, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 58.35(a)

21 CFR 58.35(b)(6)

21 CFR 58.35(b)(5)

21 CFR 58.63(a)

21 CFR 58.81(b)(10)

21 CFR 58.81(a)

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Record Information

Company

Colorado Histo-Prep

Inspection Date

May 10, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Sean Y. Kassim (Deputy Office Director)

ID: e8e6d576-e4a5-478d-a736-fc8595ad9975

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