FDA-Inspected Site

Frontage Laboratories, Inc.

12 FDA inspections are on record for Frontage Laboratories, Inc. in Exton, United States.

483· Form 483 issued

Exton, United States · Last updated July 9, 2026

Overview

  • 12 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-14.

At a glance

Inspections

12

Form 483s

6

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Apr 2026 – 14 Apr 2026Human Drugs483View 483 →
2 Sep 2025 – 5 Sep 2025Human DrugsClean
7 Jan 2025 – 10 Jan 2025Animal Drugs & Feeds483View 483 →
27 Mar 2023 – 31 Mar 2023Human DrugsClean
9 Aug 2022 – 11 Aug 2022Human Drugs483On file
31 Jan 2022 – 18 Feb 2022Human Drugs483View 483 →
12 Oct 2021 – 15 Oct 2021Human Drugs483View 483 →
28 Oct 2019 – 1 Nov 2019Human DrugsClean
7 Apr 2017 – 12 Apr 2017Human DrugsClean
10 Mar 2016 – 18 Mar 2016Human Drugs483On file
17 Jan 2012Not recordedClean
19 Mar 2010Not recordedClean

Observations on record

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

14 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Junho Pak

14 Apr 2026
21 CFR 211.192

Written record of investigation incomplete

Cited by Junho Pak

14 Apr 2026
21 CFR 211.194(a)(4)

Data secured in course of each test

Cited by Junho Pak

14 Apr 2026
21 CFR 211.68(b)

Backup file not maintained

Cited by Junho Pak

10 Jan 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Anastasia M Shields, Jenny Sung

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.25(c)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)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 Frontage Laboratories, Inc.'s 6 Form 483s

Source PDFs 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