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Form 483

Repro-Med Systems, Inc. Form 483, 2017-10-19

FDA issued a Form 483 to Repro-Med Systems, Inc. on 2017-10-19 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Repro-Med Systems, Inc. · Chester, United States · Issued October 19, 2017

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

RSRepro-Med Systems, Inc.Chester, United States

Inspection team

LLLi Li

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere