FDA WARNING_LETTER - Prodigy Diabetes Care, LLC - April 16, 2012

FDA WARNING_LETTER for Prodigy Diabetes Care, LLC on April 16, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Prodigy Diabetes Care, LLC on April 16, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.250(a)

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

21 CFR 820.250(b)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 803

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

Prodigy Diabetes Care, LLC

Inspection Date

April 16, 2012

Product Type

Devices

Office

Atlanta District Office

People

John R. Gridley

ID: d81a945a-90b7-43c1-b10b-96edcf1581f6

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