Atlas

FDA-Inspected Site

Apozeal Pharmaceuticals Inc.

13 FDA inspections are on record for Apozeal Pharmaceuticals Inc. in Levittown, United States.

483· Form 483 issued

Levittown, United States · Last updated July 9, 2026

Overview

  • 13 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-15.

At a glance

Inspections

13

Form 483s

8

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Oct 2025 – 15 Oct 2025Human Drugs483View 483 →
6 Dec 2021 – 15 Dec 2021Human DrugsClean
11 Mar 2019 – 9 Apr 2019Human DrugsWLView 483 →
7 Nov 2018 – 9 Nov 2018Human DrugsClean
16 Jul 2018 – 26 Jul 2018Human Drugs483View 483 →
25 Jan 2018 – 7 Feb 2018Human Drugs483View 483 →
15 Mar 2017 – 5 Apr 2017Human Drugs483View 483 →
27 Sep 2016Human DrugsClean
21 Nov 2012Not recorded483View 483 →
27 Oct 2009Not recorded483View 483 →
31 Mar 2008Not recorded483On file
26 Mar 2007Not recordedClean

Observations on record

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

15 Oct 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Brandy N Lepage

15 Oct 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Brandy N Lepage

15 Oct 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brandy N Lepage

15 Oct 2025
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Brandy N Lepage

15 Oct 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Brandy N Lepage

Investigators

FDA investigators tied to this site in the record.

Christina K Theodorou3 insp.
Lisa B Orr3 insp.
Anastasia M Shields2 insp.
Brandy N Lepage1 insp.
Junho Pak1 insp.
Karen A Briggs1 insp.
Dandan Wang1 insp.
Thomas E Friel1 insp.
Anita R Michael1 insp.
Julianne C Mccullough1 insp.
Denise M Digiulio1 insp.
Maria A Reed1 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 observations7x
21 CFR 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.67(b)Cited across public-safe Form 483 observations5x
21 CFR 211.100(a)Cited across public-safe Form 483 observations4x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations4x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Apozeal Pharmaceuticals Inc.'s 8 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