Atlas

FDA-Inspected Site

Repro-Med Systems, Inc.

8 FDA inspections are on record for Repro-Med Systems, Inc. in Chester, United States.

483· Form 483 issued

Chester, United States · Last updated July 9, 2026

Overview

  • 8 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-10-19.

At a glance

Inspections

8

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Oct 2017 – 19 Oct 2017Medical Devices & Rad Health483View 483 →
29 Nov 2016 – 16 Dec 2016Medical Devices & Rad Health483View 483 →
3 Jun 2015 – 23 Jun 2015Medical Devices & Rad Health483View 483 →
3 Jun 2015 – 9 Jun 2015Medical Devices & Rad Health483On file
20 Jul 2012Not recordedClean
21 Sep 2010Not recordedClean
28 Oct 2009Not recorded483View 483 →
7 Jun 2001Not recordedClean

Observations on record

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

19 Oct 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Li Li

19 Oct 2017
21 CFR 820.30(g)

Design validation - simulated testing

Cited by Li Li

19 Oct 2017
21 CFR 820.30(g)

Design validation - simulated testing

Cited by Li Li

19 Oct 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Li Li

19 Oct 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Li Li

Investigators

FDA investigators tied to this site in the record.

Jacqueline S Warner2 insp.
Paul E Stein2 insp.
Li Li1 insp.
Scott R Izyk1 insp.
Catherine M Beer1 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 observations7x
21 CFR 820.30(f)Cited across public-safe Form 483 observations4x
21 CFR 820.30(i)Cited across public-safe Form 483 observations4x
21 CFR 820.90(a)Cited across public-safe Form 483 observations4x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.160(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(c)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.30(b)Cited across public-safe Form 483 observations2x
21 CFR 820.30(h)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(e)Cited across public-safe Form 483 observations2x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Repro-Med Systems, Inc.'s 5 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