Agendia, Inc.

Form 483

Irvine, California, United StatesFEI 3007297853Issued August 22, 2017

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 3007297853.

Observations5

Issue DateAugust 22, 2017

StatusNo Warning Letter

Related Inspections4

Establishment Details

Firm: Agendia, Inc.
Location: Irvine, California, United States
FEI Number: 3007297853
Product Type: Devices
Issue Date: August 22, 2017
Country: United States

Inspection History, 2011 to 2024

NAI1

VAI3

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

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Agendia, Inc. FDA Form 483, Irvine, California, August 22, 2017