FDA Inspection 957490 - Neusoft Medical Systems Co., Ltd. - January 29, 2016

FDA Inspection 957490 for Neusoft Medical Systems Co., Ltd. on January 29, 2016. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 957490 for Neusoft Medical Systems Co., Ltd. on January 29, 2016. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 1002.20(a)

21 CFR 1020.30(k)

21 CFR 803.17(a)(3)

21 CFR 806.20(b)(4)

21 CFR 820.100(a)

21 CFR 820.30(h)

21 CFR 820.90(a)

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Record Information

Company

Neusoft Medical Systems Co., Ltd.

Inspection Date

January 29, 2016

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f9cc141b-5edc-4fab-8bf9-6095244bce8a

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