FDA Inspection 1059095 - OriGen Biomedical, Inc. - July 05, 2018

FDA Inspection 1059095 for OriGen Biomedical, Inc. on July 05, 2018. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1059095 for OriGen Biomedical, Inc. on July 05, 2018. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.50(a)(1)

21 CFR 806.10(a)(1)

21 CFR 820.22

21 CFR 820.40

21 CFR 820.90(b)(2)

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Record Information

Company

OriGen Biomedical, Inc.

Inspection Date

July 5, 2018

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f8ab3f20-a48c-4b75-86ea-755b25a0aa05

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