Form 483

Zingerman's Creamery, LLC Form 483, 2022-07-01

FDA issued a Form 483 to Zingerman's Creamery, LLC on 2022-07-01 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Zingerman's Creamery, LLC · Ann Arbor, United States · Issued July 1, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

1 Jul 2022
21 CFR 117.135(c)(2)

Allergen preventive controls - Appropriate (Adequate)

Cited by Alexandra A Carrico, Misty D Harvey

1 Jul 2022
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Alexandra A Carrico, Misty D Harvey

Inspected site

ZCZingerman's Creamery, LLCAnn Arbor, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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