Form 483

Mainstreet Bakery Holdings LLC Form 483, 2019-10-10

FDA issued a Form 483 to Mainstreet Bakery Holdings LLC on 2019-10-10 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Mainstreet Bakery Holdings LLC · Edina, United States · Issued October 10, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Oct 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Zachary P Wachlarowicz, Douglas J Snyder

10 Oct 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Zachary P Wachlarowicz, Douglas J Snyder

Inspected site

MBMainstreet Bakery Holdings LLCEdina, 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 observations2x

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