FDA WARNING_LETTER - Laser Engineering, Inc. - April 04, 2014

FDA WARNING_LETTER for Laser Engineering, Inc. on April 04, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Laser Engineering, Inc. on April 04, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

21 CFR 1040.10

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

21 CFR 1040.10(h)(1)(i)

21 CFR 820.72(b)

21 CFR 820.40(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 1002.11

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Record Information

Company

Laser Engineering, Inc.

Inspection Date

April 4, 2014

Product Type

Devices

Office

New Orleans District Office

People

Kimberly L. McMillan (Acting Program Director)

ID: 444f6ecb-709c-4135-8ffa-6a9fffdb6542

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