FDA Inspection 939204 - Sciton Inc. - August 20, 2015

FDA Inspection 939204 for Sciton Inc. on August 20, 2015. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 939204 for Sciton Inc. on August 20, 2015. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 1002.13

21 CFR 1002.20(a)

21 CFR 803.50(a)(1)

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.198(d)

21 CFR 820.25(b)

21 CFR 820.30(g)

21 CFR 820.70(a)

21 CFR 820.75(b)(2)

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Record Information

Company

Sciton Inc.

Inspection Date

August 20, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f80d528e-d7be-4509-8b19-af13ee7f4587

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