FDA WARNING_LETTER - Animas Corporation - August 10, 2011

FDA WARNING_LETTER for Animas Corporation on August 10, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Animas Corporation on August 10, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.20(c)

21 CFR 803

21 U.S.C. 351(h)

21 CFR 820.100(a)(3)

21 U.S.C. 360i

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Record Information

Company

Animas Corporation

Inspection Date

August 10, 2011

Product Type

Devices

Office

Department of Health and Human Services

People

ID: 78d8e4fc-7edf-4d46-8776-ba0c6e726cef

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