Form 483

La Crocante Fine Foods Distributor, LLC Form 483, 2016-06-06

FDA issued a Form 483 to La Crocante Fine Foods Distributor, LLC on 2016-06-06 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

La Crocante Fine Foods Distributor, LLC · Miami, United States · Issued June 6, 2016

Overview

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

Inspectional observations

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

6 Jun 2016
21 CFR 110.35(a)

Buildings/good repair

Cited by Omayra N Rodriguez-Ruiz, Aaron F Coleman

6 Jun 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Omayra N Rodriguez-Ruiz, Aaron F Coleman

6 Jun 2016
21 CFR 110.35(b)(2)

Storage requirements

Cited by Omayra N Rodriguez-Ruiz, Aaron F Coleman

6 Jun 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Omayra N Rodriguez-Ruiz, Aaron F Coleman

6 Jun 2016
21 CFR 110.37(b)(5)

Cross contamination

Cited by Omayra N Rodriguez-Ruiz, Aaron F Coleman

Inspected site

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 observations2x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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