FDA WARNING_LETTER - Fenwal, a Fresenius-Kaby Company - April 25, 2013

FDA WARNING_LETTER for Fenwal, a Fresenius-Kaby Company on April 25, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Fenwal, a Fresenius-Kaby Company on April 25, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 314.81(b)(1)(i)

21 CFR 211

21 CFR 211.198(a)

21 U.S.C. 355(k)

21 CFR 210

21 CFR 211.192

21 U.S.C. 351(a)(2)(B)

21 CFR 211.130(a)

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Record Information

Company

Fenwal, a Fresenius-Kaby Company

Inspection Date

April 25, 2013

Product Type

Drugs

Office

San Juan District Office

People

ID: e798c95a-fe7a-4efc-83ee-59099e4cc1d5

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