FDA-Inspected Site

Topical Pharmaceuticals, Inc.

6 FDA inspections are on record for Topical Pharmaceuticals, Inc. in Addison, United States.

483· Form 483 issued

Addison, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-07.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Apr 2026 – 7 May 2026Human Drugs483View 483 →
28 Jun 2022 – 30 Jun 2022Human Drugs483On file
6 Jun 2019Foods & CosmeticsClean
23 Jun 2016 – 7 Jul 2016Human DrugsClean
18 Jan 2011Not recorded483View 483 →
8 Mar 2007Not recordedClean

Observations on record

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

7 May 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gabriel Bermudez-Picart, Angela C Welker, Scott D Mcgrew, Chikitsa S Patel

7 May 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Gabriel Bermudez-Picart, Angela C Welker, Scott D Mcgrew, Chikitsa S Patel

7 May 2026
21 CFR 211.165(a)

Testing and release for distribution

Cited by Gabriel Bermudez-Picart, Angela C Welker, Scott D Mcgrew, Chikitsa S Patel

7 May 2026
21 CFR 211.180(e)(2)

Items to cover on annual reviews

Cited by Gabriel Bermudez-Picart, Angela C Welker, Scott D Mcgrew, Chikitsa S Patel

7 May 2026
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Gabriel Bermudez-Picart, Angela C Welker, Scott D Mcgrew, Chikitsa S Patel

Investigators

FDA investigators tied to this site in the record.

Scott D Mcgrew1 insp.
Chikitsa S Patel1 insp.
Christina A Miller1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited 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 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Topical Pharmaceuticals, Inc.'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