FDA WARNING_LETTER - IriSys, Inc. - April 01, 2010

FDA WARNING_LETTER for IriSys, Inc. on April 01, 2010. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for IriSys, Inc. on April 01, 2010. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(d)

21 U.S.C. 321(p)

FD&C Act 501(a)(2)(B)

21 CFR 211.160(b)

21 U.S.C. 331(a)

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

21 CFR 211

21 CFR 211.67(a)

21 U.S.C. 321(g)(1)(B)

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Record Information

Company

IriSys, Inc.

Inspection Date

April 1, 2010

Product Type

Drugs

Office

Los Angeles District Office

People

ID: 38d4311c-368c-4482-88da-43f3b2f2fb8c

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