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Form 483

Micro Stamping Corp Form 483, 2020-02-25

FDA issued a Form 483 to Micro Stamping Corp on 2020-02-25 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Micro Stamping Corp · Somerset, United States · Issued February 25, 2020

Overview

  • 4 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.

25 Feb 2020
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Gobiga Vanniyasingam

25 Feb 2020
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Gobiga Vanniyasingam

25 Feb 2020
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Gobiga Vanniyasingam

25 Feb 2020
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Gobiga Vanniyasingam

Inspected site

MSMicro Stamping CorpSomerset, United States

Inspection team

GVGobiga Vanniyasingam

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited 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 4 observations

The source PDF, 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