OriGen Biomedical, Inc.

Form 483FOIA Uncovered

Austin, Texas, United StatesFEI 1000160256Issued July 05, 2018

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000160256.

Observations5

Issue DateJuly 05, 2018

Status1 Related Warning Letter

Related Inspections3

Establishment Details

Firm: OriGen Biomedical, Inc.
Location: Austin, Texas, United States
FEI Number: 1000160256
Product Type: Devices
Issue Date: July 05, 2018
Country: United States

Inspection History, 2013 to 2020

NAI1

VAI1

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

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OriGen Biomedical, Inc. FDA Form 483, Austin, Texas, July 5, 2018