Form 483

Micro Typing Systems, Inc. Form 483, 2016-01-15

FDA issued a Form 483 to Micro Typing Systems, Inc. on 2016-01-15 with 9 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health9 observations

Micro Typing Systems, Inc. · Pompano Beach, United States · Issued January 15, 2016

Overview

  • 9 public-safe observations are available for this inspection.
  • 3 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.

15 Jan 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Sean T Creighton

15 Jan 2016
21 CFR 820.198(e)

Records of complaint investigation

Cited by Sean T Creighton

15 Jan 2016
21 CFR 820.75(a)

Documentation

Cited by Sean T Creighton

15 Jan 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Sean T Creighton

15 Jan 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Sean T Creighton

Inspected site

MTMicro Typing Systems, Inc.Pompano Beach, United States

Inspection team

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 820.198(e)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 observations

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