Atlas

Form 483

Fresh Express Incorporated Form 483, 2012-05-30

FDA issued a Form 483 to Fresh Express Incorporated on 2012-05-30 with 3 public-safe observations.

483· Form 483 issued3 observations

Fresh Express Incorporated · Salinas, United States · Issued May 30, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

30 May 2012
21 CFR 110.35(b)(1)

Safe and adequate for use

Cited by Estefania Fernandez, Cindy W Lewis, Mabel M Lee

30 May 2012
21 CFR 110.80

Supervisory competence

Cited by Estefania Fernandez, Cindy W Lewis, Mabel M Lee

30 May 2012
21 CFR 110.80

Testing

Cited by Estefania Fernandez, Cindy W Lewis, Mabel M Lee

Inspected site

FEFresh Express IncorporatedSalinas, United States

Inspection team

EFEstefania Fernandez
CWCindy W Lewis
MMMabel M Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80Cited across public-safe Form 483 observations2x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, 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