Form 483

Fruit Fresh Up, Inc. Form 483, 2023-03-20

FDA issued a Form 483 to Fruit Fresh Up, Inc. on 2023-03-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Fruit Fresh Up, Inc. · Depew, United States · Issued March 20, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

20 Mar 2023
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Diamond M Oden, Joshua D Lopez, Elizabeth H Slazak

20 Mar 2023
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Diamond M Oden, Joshua D Lopez, Elizabeth H Slazak

20 Mar 2023
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Diamond M Oden, Joshua D Lopez, Elizabeth H Slazak

Inspected site

FFFruit Fresh Up, Inc.Depew, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(3)Cited 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 3 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