FDA Inspection 829344 - Laser Engineering, Inc. - April 17, 2013

FDA Inspection 829344 for Laser Engineering, Inc. on April 17, 2013. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 829344 for Laser Engineering, Inc. on April 17, 2013. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 1002.13

21 CFR 1040.10(f)(1)

21 CFR 1040.10(f)(2)(i)

21 CFR 1040.10(g)(5)(i)

21 CFR 1040.10(g)(7)(v)

21 CFR 1040.10(h)(1)(vi)

21 CFR 1040.10(h)(2)(ii)

21 CFR 820.100(b)

21 CFR 820.184

21 CFR 820.198(a)

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Record Information

Company

Laser Engineering, Inc.

Inspection Date

April 17, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: 22e5d9cf-41bc-41fa-8a93-337f595f50eb

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