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Form 483

Martech Medical Products, Inc. Form 483, 2015-09-21

FDA issued a Form 483 to Martech Medical Products, Inc. on 2015-09-21 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Martech Medical Products, Inc. · Harleysville, United States · Issued September 21, 2015

Overview

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

Inspectional observations

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

21 Sep 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Edwin L Hobbs, Raffi B Papazian

21 Sep 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Edwin L Hobbs, Raffi B Papazian

Inspected site

MMMartech Medical Products, Inc.Harleysville, United States

Inspection team

ELEdwin L Hobbs
RBRaffi B Papazian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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