Atlas

Form 483

Morris Innovative, Inc. Form 483, 2013-02-01

FDA issued a Form 483 to Morris Innovative, Inc. on 2013-02-01 with 2 public-safe observations.

483· Form 483 issued2 observations

Morris Innovative, Inc. · Bloomington, United States · Issued February 1, 2013

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.

1 Feb 2013
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Robert M Barbosa, Patrick B Cummings

1 Feb 2013
21 CFR 820.100(b)

Documentation

Cited by Robert M Barbosa, Patrick B Cummings

Inspected site

MIMorris Innovative, Inc.Bloomington, United States

Inspection team

RMRobert M Barbosa
PBPatrick B Cummings

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 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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