Form 483

Yia Yia's Bakery, Inc. Form 483, 2020-03-23

FDA issued a Form 483 to Yia Yia's Bakery, Inc. on 2020-03-23 with 16 public-safe observations.

483· Form 483 issuedFoods & Cosmetics16 observations

Yia Yia's Bakery, Inc. · Baltimore, United States · Issued March 23, 2020

Overview

  • 16 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

23 Mar 2020
21 CFR 117.10

Personnel

Cited by Karen A Spencer, Natasha A Dezinna, Upendra Paudel

23 Mar 2020
21 CFR 117.10

Personnel

Cited by Karen A Spencer, Natasha A Dezinna, Upendra Paudel

23 Mar 2020
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Karen A Spencer, Natasha A Dezinna, Upendra Paudel

23 Mar 2020
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Karen A Spencer, Natasha A Dezinna, Upendra Paudel

23 Mar 2020
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Karen A Spencer, Natasha A Dezinna, Upendra Paudel

Inspected site

YYYia Yia's Bakery, Inc.Baltimore, 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 observations4x
21 CFR 117.165(b)Cited across public-safe Form 483 observations4x
21 CFR 117.10Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.145(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 16 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