Form 483

Michael Foods Inc. Form 483, 2021-12-08

FDA issued a Form 483 to Michael Foods Inc. on 2021-12-08 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Michael Foods Inc. · Elizabeth, United States · Issued December 8, 2021

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.

8 Dec 2021
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Kyle D Covill

8 Dec 2021
21 CFR 117.150(d)

Sanitation Controls Corrective Action Records

Cited by Kyle D Covill

8 Dec 2021
21 CFR 117.155(b)

Process Controls Verification Records

Cited by Kyle D Covill

Inspected site

MFMichael Foods Inc.Elizabeth, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations1x
21 CFR 117.150(d)Cited across public-safe Form 483 observations1x
21 CFR 117.155(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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