FDA WARNING_LETTER - Lusys Laboratories, Inc. - May 15, 2015

FDA WARNING_LETTER for Lusys Laboratories, Inc. on May 15, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lusys Laboratories, Inc. on May 15, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.80(d)

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

21 CFR 820.30(a)

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

21 CFR 820.100(a)

21 CFR 820.70(c)

21 CFR 820

21 U.S.C. 382(f)(1)

21 U.S.C. 321(h)

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Record Information

Company

Lusys Laboratories, Inc.

Inspection Date

May 15, 2015

Product Type

Devices

Office

Los Angeles District Office

People

ID: 8f44cfc5-6e7b-4d05-a605-2a283cf063c1

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