Atlas

FDA-Inspected Site

AVEXIS

2 FDA inspections are on record for AVEXIS in Libertyville, United States.

483· Form 483 issued

Libertyville, United States · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-06-16.

At a glance

Inspections

2

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Jun 2021 – 16 Jun 2021Biologics483View 483 →
4 Feb 2019 – 8 Feb 2019Biologics483On file

Observations on record

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

16 Jun 2021
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Lewis K Antwi, Jacqueline M Diaz Albert, Steven E Bowen, Jacqueline M Diaz Albertini

16 Jun 2021
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Lewis K Antwi, Jacqueline M Diaz Albert, Steven E Bowen, Jacqueline M Diaz Albertini

16 Jun 2021
21 CFR 211.170(b)(1)

Retention time of reserve samples, in general

Cited by Lewis K Antwi, Jacqueline M Diaz Albert, Steven E Bowen, Jacqueline M Diaz Albertini

16 Jun 2021
21 CFR 211.194(a)

Complete test data included in records

Cited by Lewis K Antwi, Jacqueline M Diaz Albert, Steven E Bowen, Jacqueline M Diaz Albertini

16 Jun 2021
21 CFR 212.40(b)

Written specifications - components

Cited by Lewis K Antwi, Jacqueline M Diaz Albert, Steven E Bowen, Jacqueline M Diaz Albertini

Investigators

FDA investigators tied to this site in the record.

Lewis K Antwi1 insp.
Jacqueline M Diaz Albert1 insp.
Steven E Bowen1 insp.
Jacqueline M Diaz Albertini1 insp.
Burnell M Henry1 insp.
Wei Wang1 insp.
Deborah M Trout1 insp.
Andrew P Byrnes1 insp.
Angela S Whatley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 212.40(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind AVEXIS' 2 Form 483s

Source PDFs and 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