FDA Inspection 1089611 - Infinium Medical, Inc - May 15, 2019

FDA Inspection 1089611 for Infinium Medical, Inc on May 15, 2019. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1089611 for Infinium Medical, Inc on May 15, 2019. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.100(a)

21 CFR 820.181

21 CFR 820.198(a)

21 CFR 820.50

21 CFR 820.70(b)

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Record Information

Company

Infinium Medical, Inc

Inspection Date

May 15, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fa13fe6c-d988-47f4-a790-1869365d88df

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