Form 483

Midwest Products and Engineering, Inc. Form 483, 2023-04-21

FDA issued a Form 483 to Midwest Products and Engineering, Inc. on 2023-04-21 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Midwest Products and Engineering, Inc. · Milwaukee, United States · Issued April 21, 2023

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

21 Apr 2023
21 CFR 820.100(b)

Documentation

Cited by Amanda Dinaro

21 Apr 2023
21 CFR 820.100(b)

Documentation

Cited by Amanda Dinaro

21 Apr 2023
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Amanda Dinaro

21 Apr 2023
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Amanda Dinaro

21 Apr 2023
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Amanda Dinaro

Inspected site

MPMidwest Products and Engineering, Inc.Milwaukee, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.20(a)Cited across public-safe Form 483 observations2x
21 CFR 820.70(c)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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