Atlas

FDA-Inspected Site

Epimed International, Inc.

8 FDA inspections are on record for Epimed International, Inc. in Johnstown, United States.

483· Form 483 issued

Johnstown, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-12-12.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Dec 2018 – 12 Dec 2018Medical Devices & Rad Health483On file
26 May 2016 – 12 Jul 2016Medical Devices & Rad Health483View 483 →
29 Oct 2013 – 6 Nov 2013Medical Devices & Rad Health483View 483 →
13 Mar 2013 – 26 Mar 2013Medical Devices & Rad Health483View 483 →
17 May 2012Not recordedWLOn file
13 Apr 2010Not recorded483View 483 →
18 Nov 2005Not recordedClean
24 Feb 2005Not recordedClean

Observations on record

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

12 Jul 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Scott R Izyk

12 Jul 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Scott R Izyk

12 Jul 2016
21 CFR 803.56

Submission Within One Month

Cited by Scott R Izyk

12 Jul 2016
21 CFR 803.56

Submission Within One Month

Cited by Scott R Izyk

12 Jul 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Scott R Izyk

Investigators

FDA investigators tied to this site in the record.

Catherine M Beer4 insp.
MDSAP harperd1 insp.
Scott R Izyk1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x
21 CFR 820.198(a)Cited across public-safe Form 483 observations5x
21 CFR 820.30(g)Cited across public-safe Form 483 observations5x
21 CFR 820.75(a)Cited across public-safe Form 483 observations5x
21 CFR 820.80(b)Cited across public-safe Form 483 observations5x
21 CFR 803.17Cited across public-safe Form 483 observations4x
21 CFR 803.56Cited across public-safe Form 483 observations4x
21 CFR 820.181Cited across public-safe Form 483 observations4x
21 CFR 820.30(b)Cited across public-safe Form 483 observations4x
21 CFR 820.30(c)Cited across public-safe Form 483 observations4x
21 CFR 820.30(h)Cited across public-safe Form 483 observations4x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations4x
21 CFR 820.90(a)Cited across public-safe Form 483 observations4x
21 CFR 820.70(a)Cited across public-safe Form 483 observations2x
21 CFR 803.18(b)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Epimed International, Inc.'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