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Form 483

Micro Typing Systems, Inc. Form 483, 2021-11-22

FDA issued a Form 483 to Micro Typing Systems, Inc. on 2021-11-22 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Micro Typing Systems, Inc. · Pompano Beach, United States · Issued November 22, 2021

Overview

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

Inspectional observations

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

22 Nov 2021
21 CFR 820.100(b)

Documentation

Cited by Susan M Jackson, Laurel A Beer

22 Nov 2021
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Susan M Jackson, Laurel A Beer

Inspected site

MTMicro Typing Systems, Inc.Pompano Beach, United States

Inspection team

SMSusan M Jackson
LALaurel A Beer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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