Form 483

Vitony Bakery, Inc. Form 483, 2024-03-12

FDA issued a Form 483 to Vitony Bakery, Inc. on 2024-03-12 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Vitony Bakery, Inc. · Catano, United States · Issued March 12, 2024

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

12 Mar 2024
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Jose Perez-Soto, Leslie A Mendoza, Katherine Vargas-Serrano

12 Mar 2024
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Jose Perez-Soto, Leslie A Mendoza, Katherine Vargas-Serrano

12 Mar 2024
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Jose Perez-Soto, Leslie A Mendoza, Katherine Vargas-Serrano

12 Mar 2024
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Jose Perez-Soto, Leslie A Mendoza, Katherine Vargas-Serrano

12 Mar 2024
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Jose Perez-Soto, Leslie A Mendoza, Katherine Vargas-Serrano

Inspected site

VBVitony Bakery, Inc.Catano, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations2x
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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