Form 483

San Marco Bakery, Inc Form 483, 2020-09-25

FDA issued a Form 483 to San Marco Bakery, Inc on 2020-09-25 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

San Marco Bakery, Inc · Burbank, United States · Issued September 25, 2020

Overview

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

25 Sep 2020
21 CFR 117.10

Personnel

Cited by Greg K Keshishyan, Loretta J Miller

25 Sep 2020
21 CFR 117.35(d)

Sanitation of food contact surfaces - frequency

Cited by Greg K Keshishyan, Loretta J Miller

25 Sep 2020
21 CFR 117.35(e)

Sanitation of non-food contact surfaces - frequency

Cited by Greg K Keshishyan, Loretta J Miller

25 Sep 2020
21 CFR 117.4

Training of employees and records

Cited by Greg K Keshishyan, Loretta J Miller

25 Sep 2020
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Greg K Keshishyan, Loretta J Miller

Inspected site

SMSan Marco Bakery, IncBurbank, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x
21 CFR 117.35(e)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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