FDA Inspection 962346 - GelCool Systems, Inc - March 07, 2016

FDA Inspection 962346 for GelCool Systems, Inc on March 07, 2016. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 962346 for GelCool Systems, Inc on March 07, 2016. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.17

21 CFR 820.198(a)

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Record Information

Company

GelCool Systems, Inc

Inspection Date

March 7, 2016

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fdcae17b-db15-44ff-b7fb-96a6801a95e5

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