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Form 483

Mead Johnson & Company, LLC Form 483, 2011-09-27

FDA issued a Form 483 to Mead Johnson & Company, LLC on 2011-09-27 with 3 public-safe observations.

483· Form 483 issued3 observations

Mead Johnson & Company, LLC · Evansville, United States · Issued September 27, 2011

Overview

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

27 Sep 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Ifueko Osemwota, Larry K Austin

27 Sep 2011
21 CFR 110.80

Reasonable precautions

Cited by Ifueko Osemwota, Larry K Austin

27 Sep 2011
21 CFR 110.80(b)(8)

Metal / extraneous materials

Cited by Ifueko Osemwota, Larry K Austin

Inspected site

MJMead Johnson & Company, LLCEvansville, United States

Inspection team

IOIfueko Osemwota
LKLarry K Austin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited 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 3 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