Form 483

Midwest PMS LLC Form 483, 2012-02-09

FDA issued a Form 483 to Midwest PMS LLC on 2012-02-09 with 3 public-safe observations.

483· Form 483 issued3 observations

Midwest PMS LLC · Fort Morgan, United States · Issued February 9, 2012

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.

9 Feb 2012
21 CFR 225.30(b)(4)

Calibration of scales and metering devices

Cited by Zachary L Stamm, Isaiah Isakson

9 Feb 2012
21 CFR 225.58(e)

Distribution discontinued

Cited by Zachary L Stamm, Isaiah Isakson

9 Feb 2012
21 CFR 225.65(b)

Reasonable and effective procedures followed

Cited by Zachary L Stamm, Isaiah Isakson

Inspected site

MPMidwest PMS LLCFort Morgan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.30(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 225.58(e)Cited across public-safe Form 483 observations1x
21 CFR 225.65(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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