FDA-Inspected Site

Avera McKennan

1 FDA inspection is on record for Avera McKennan in Sioux Falls, United States.

483· Form 483 issued

Sioux Falls, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-23.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Jun 2026 – 23 Jun 2026Biologics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

23 Jun 2026
21 CFR 606.65(e)

Following manufacturer's instructions

Cited by Michele Gottshall

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 606.65(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Avera McKennan's 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat