FDA WARNING_LETTER - Penumbra, Inc. - August 28, 2009

FDA WARNING_LETTER for Penumbra, Inc. on August 28, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Penumbra, Inc. on August 28, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(h)

21 U.S.C. 351(h)

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

21 U.S.C. 360i

21 CFR 820

21 CFR 820.100(a)

21 CFR 820.100(a)(3)

21 CFR 820.198(a)

21 CFR 820.198(d)

21 CFR 820.90(a)

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Record Information

Company

Penumbra, Inc.

Inspection Date

August 28, 2009

Product Type

Devices

Office

San Francisco District Office

People

ID: 753a098d-c451-416e-ab68-c351da537e6c

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