Atlas

FDA-Inspected Site

Denison Pharmaceuticals, LLC

16 FDA inspections are on record for Denison Pharmaceuticals, LLC in Lincoln, United States.

483· Form 483 issued

Lincoln, United States · Last updated July 9, 2026

Overview

  • 16 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-26.

At a glance

Inspections

16

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 Jun 2025 – 26 Aug 2025Foods & Cosmetics483View 483 →
26 Jun 2025 – 2 Jul 2025Foods & CosmeticsClean
26 Jun 2025Foods & CosmeticsClean
17 Jun 2024 – 29 Jul 2024Human Drugs483View 483 →
5 Jan 2023 – 9 Feb 2023Human DrugsWLView 483 →
17 Oct 2017 – 25 Oct 2017Animal Drugs & Feeds483View 483 →
22 Mar 2016 – 5 Apr 2016Human Drugs483View 483 →
12 Mar 2013 – 15 Mar 2013Human DrugsClean
7 Oct 2010Not recordedClean
5 Aug 2009Not recorded483View 483 →
21 Dec 2005Not recordedClean
14 May 2003Not recordedClean

Observations on record

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

26 Aug 2025
21 CFR 111.10(b)

Hygienic practices

Cited by Kimberly M White

26 Aug 2025
21 CFR 111.15(b)

Physical plant - clean and sanitary

Cited by Kimberly M White

26 Aug 2025
21 CFR 111.16

Written procedures - follow; cleaning

Cited by Kimberly M White

29 Jul 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor

29 Jul 2024
21 CFR 211.101(d)

Component addition checked by 2nd person

Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor

Investigators

FDA investigators tied to this site in the record.

Kimberly M White3 insp.
Daniel L Zheng2 insp.
Lori M Newman2 insp.
Jonathan G Matrisciano2 insp.
Ifechimere I Okafor1 insp.
Sean R Marcsisin1 insp.
Nealie C Newberger1 insp.
Kenneth H Williams1 insp.
Paraluman S Leonin1 insp.
Paula M Laplant1 insp.
Laurie B Frazier1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations8x
21 CFR 211.192Cited across public-safe Form 483 observations7x
21 CFR 211.165(e)Cited across public-safe Form 483 observations5x
21 CFR 211.25(a)Cited across public-safe Form 483 observations5x
21 CFR 211.58Cited across public-safe Form 483 observations5x
21 CFR 211.160(a)Cited across public-safe Form 483 observations4x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 111.10(b)Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)Cited across public-safe Form 483 observations1x
21 CFR 111.16Cited across public-safe Form 483 observations1x
21 CFR 211.101(d)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.94(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Denison Pharmaceuticals, LLC's 6 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