FDA WARNING_LETTER - Lucero Medical, LLC - November 22, 2011

FDA WARNING_LETTER for Lucero Medical, LLC on November 22, 2011. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lucero Medical, LLC on November 22, 2011. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

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

21 CFR 820.30(a)

21 U.S.C. 351(f)(1)(B)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 820.198(a)

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Record Information

Company

Lucero Medical, LLC

Inspection Date

November 22, 2011

Product Type

Devices

Office

Cincinnati District Office

People

Paul J. Teitell (District Director)

ID: a5fba76e-bab8-4a26-8dab-780d09dd6391

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