Atlas

Form 483

Midwest Performance Pack, Inc. Form 483, 2011-06-30

FDA issued a Form 483 to Midwest Performance Pack, Inc. on 2011-06-30 with 3 public-safe observations.

483· Form 483 issued3 observations

Midwest Performance Pack, Inc. · Blanchard, United States · Issued June 30, 2011

Overview

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

30 Jun 2011
21 CFR 110.37(e)(2)

Hand cleaning and sanitizing preparations

Cited by Danielle Lyke

30 Jun 2011
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Danielle Lyke

30 Jun 2011
21 CFR 110.93

Storage/transportation of finished goods (contamination)

Cited by Danielle Lyke

Inspected site

MPMidwest Performance Pack, Inc.Blanchard, United States

Inspection team

DLDanielle Lyke

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited 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