Form 483

Fresh Express Incorporated Form 483, 2011-07-13

FDA issued a Form 483 to Fresh Express Incorporated on 2011-07-13 with 2 public-safe observations.

483· Form 483 issued2 observations

Fresh Express Incorporated · Salinas, United States · Issued July 13, 2011

Overview

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

Inspectional observations

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

13 Jul 2011
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee, Ingrid A Zambrana

13 Jul 2011
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee, Ingrid A Zambrana

Inspected site

FEFresh Express IncorporatedSalinas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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