FDA WARNING_LETTER - GyNova LLC - November 05, 2007

FDA WARNING_LETTER for GyNova LLC on November 05, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GyNova LLC on November 05, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(a)

21 CFR 820.198

21 U.S.C. 321(h)

21 CFR 820.25(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.184

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Record Information

Company

GyNova LLC

Inspection Date

November 5, 2007

Product Type

Devices

Office

New England District Office

People

Michael R. Kravchuk (Retired Director)

ID: 82dae713-1db5-4f95-933d-b8178bfd8b63

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