Atlas

Form 483

Nutri-Dyn Midwest, Inc. Form 483, 2011-07-20

FDA issued a Form 483 to Nutri-Dyn Midwest, Inc. on 2011-07-20 with 5 public-safe observations.

483· Form 483 issued5 observations

Nutri-Dyn Midwest, Inc. · Maple Plain, United States · Issued July 20, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

20 Jul 2011
21 CFR 111.103

Written procedures - quality control operations

Cited by Marie A Fadden

20 Jul 2011
21 CFR 111.113

Quality control operations - material review, disposition

Cited by Marie A Fadden

20 Jul 2011
21 CFR 111.153

Written procedures - labels

Cited by Marie A Fadden

20 Jul 2011
21 CFR 111.453

Written procedures - holding

Cited by Marie A Fadden

20 Jul 2011
21 CFR 111.553

Written procedures - product complaint

Cited by Marie A Fadden

Inspected site

NMNutri-Dyn Midwest, Inc.Maple Plain, United States

Inspection team

MAMarie A Fadden

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.113Cited across public-safe Form 483 observations1x
21 CFR 111.153Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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