FDA Inspection 913137 - Sckoon, Inc. - February 09, 2015

FDA Inspection 913137 for Sckoon, Inc. on February 09, 2015. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 913137 for Sckoon, Inc. on February 09, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17

21 CFR 820.100(a)

21 CFR 820.181

21 CFR 820.184

21 CFR 820.198(a)

21 CFR 820.20(e)

21 CFR 820.22

21 CFR 820.30(a)

21 CFR 820.40

21 CFR 820.50

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Record Information

Company

Sckoon, Inc.

Inspection Date

February 9, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f6521abc-c2b2-4dc9-9e49-c45b269c6966

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