Form 483

Mead Johnson & Company, LLC Form 483, 2017-05-16

FDA issued a Form 483 to Mead Johnson & Company, LLC on 2017-05-16 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Mead Johnson & Company, LLC · Wanamingo, United States · Issued May 16, 2017

Overview

  • 4 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.

16 May 2017
21 CFR 106.100(f)(4)

Record - date, time

Cited by Karen M Labounty, Zachary P Wachlarowicz

16 May 2017
21 CFR 106.100(f)(4)

Record - date, time

Cited by Karen M Labounty, Zachary P Wachlarowicz

16 May 2017
21 CFR 110.10(b)(5)

Glove condition

Cited by Karen M Labounty, Zachary P Wachlarowicz

16 May 2017
21 CFR 110.10(b)(5)

Glove condition

Cited by Karen M Labounty, Zachary P Wachlarowicz

Inspected site

MJMead Johnson & Company, LLCWanamingo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 106.100(f)(4)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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