Avera IRB

Form 483

Sioux Falls, South Dakota, United StatesFEI 1721635Issued July 26, 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 1721635.

Observations3

Issue DateJuly 26, 2018

StatusNo Warning Letter

Related Inspections4

Establishment Details

Firm: Avera IRB
Location: Sioux Falls, South Dakota, United States
FEI Number: 1721635
Product Type: Drugs
Issue Date: July 26, 2018
Country: United States

Inspection History, 2013 to 2025

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.

Avera IRB FDA Form 483, Sioux Falls, South Dakota, July 26, 2018