FDA Inspection 949799 - Helica Instruments, Ltd. - November 11, 2015

FDA Inspection 949799 for Helica Instruments, Ltd. on November 11, 2015. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 949799 for Helica Instruments, Ltd. on November 11, 2015. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.30(c)

21 CFR 820.30(e)

21 CFR 820.30(f)

21 CFR 820.30(g)

21 CFR 820.30(h)

21 CFR 820.30(i)

21 CFR 820.50

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Record Information

Company

Helica Instruments, Ltd.

Inspection Date

November 11, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fcb0defa-e6e7-4393-8713-817ce5745dc5

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