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Form 483

Morton Grove Pharmaceuticals, Inc. Form 483, 2011-04-12

FDA issued a Form 483 to Morton Grove Pharmaceuticals, Inc. on 2011-04-12 with 4 public-safe observations.

483· Form 483 issued4 observations

Morton Grove Pharmaceuticals, Inc. · Morton Grove, United States · Issued April 12, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

12 Apr 2011
21 CFR 211.100(a)

Approval and review of procedures

Cited by Lequita M Mayhew

12 Apr 2011
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Lequita M Mayhew

12 Apr 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Lequita M Mayhew

12 Apr 2011
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Lequita M Mayhew

Inspected site

MGMorton Grove Pharmaceuticals, Inc.Morton Grove, United States

Inspection team

LMLequita M Mayhew

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x

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 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