Atlas

FDA-Inspected Site

Osmotica Pharmaceutical US LLC

5 FDA inspections are on record for Osmotica Pharmaceutical US LLC in Marietta, United States.

483· Form 483 issued

Marietta, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-05-02.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Apr 2025 – 2 May 2025Human Drugs483View 483 →
5 Aug 2019 – 7 Aug 2019Human DrugsClean
15 Jan 2019 – 18 Jan 2019Human Drugs483View 483 →
9 Nov 2015 – 12 Nov 2015Human DrugsClean
22 Apr 2013 – 26 Apr 2013Human Drugs483On file

Observations on record

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

2 May 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Veronica Fuentes, Samantha E Cleek, Andrew O Ejiofor, Tomika L Crafter

2 May 2025
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Veronica Fuentes, Samantha E Cleek, Andrew O Ejiofor, Tomika L Crafter

2 May 2025
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Veronica Fuentes, Samantha E Cleek, Andrew O Ejiofor, Tomika L Crafter

2 May 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Veronica Fuentes, Samantha E Cleek, Andrew O Ejiofor, Tomika L Crafter

2 May 2025
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Veronica Fuentes, Samantha E Cleek, Andrew O Ejiofor, Tomika L Crafter

Investigators

FDA investigators tied to this site in the record.

Gideon N Esuzor2 insp.
Veronica Fuentes1 insp.
Samantha E Cleek1 insp.
Andrew O Ejiofor1 insp.
Tomika L Crafter1 insp.
Johnetta F Walters1 insp.
Jawaid Hamid1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Osmotica Pharmaceutical US LLC's 3 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