Atlas

FDA-Inspected Site

ANI Pharmaceuticals, Inc.

12 FDA inspections are on record for ANI Pharmaceuticals, Inc. in Baudette, United States.

483· Form 483 issued

Baudette, United States · Last updated August 15, 2026

Overview

  • 12 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-12-06.

At a glance

Inspections

12

Form 483s

5

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Dec 2024 – 6 Dec 2024Human Drugs483On file
14 Nov 2022 – 18 Nov 2022Human Drugs483On file
9 Apr 2019 – 12 Apr 2019Human DrugsClean
15 May 2017 – 18 May 2017Human DrugsClean
25 Jul 2016 – 28 Jul 2016Human Drugs483View 483 →
24 Sep 2013 – 27 Sep 2013Human Drugs483View 483 →
6 Jan 2012Not recordedClean
16 Sep 2011Not recordedClean
29 Jan 2010Not recorded483View 483 →
5 Oct 2007Not recordedClean
16 Aug 2002Not recordedClean
13 Jun 2002Not recordedClean

Observations on record

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

28 Jul 2016
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Courtney R Ingalsbe, Courtney R Tiegs

28 Jul 2016
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Courtney R Ingalsbe, Courtney R Tiegs

27 Sep 2013
21 CFR 211.198(a)

Procedures to be written and followed

Cited by April L Young

29 Jan 2010
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Marie A Fadden

Investigators

FDA investigators tied to this site in the record.

Charles Cote2 insp.
Lori B Wikstrom1 insp.
Nibin Varghese1 insp.
Elizabeth R Bloom1 insp.
Michele Perry-Williams1 insp.
Anders W Evenson1 insp.
Nicole C Victoria1 insp.
Anthony J Ladner1 insp.
Courtney R Ingalsbe1 insp.
Courtney R Tiegs1 insp.
April L Young1 insp.
Marie A Fadden1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ANI Pharmaceuticals, Inc.'s 5 Form 483s

Source PDFs, verbatim observations, 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