Atlas

Form 483

La Ceiba De Nicolya SA Form 483, 2013-04-04

FDA issued a Form 483 to La Ceiba De Nicolya SA on 2013-04-04 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

La Ceiba De Nicolya SA · Nicoya, Costa Rica · Issued April 4, 2013

Overview

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

Inspectional observations

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

4 Apr 2013
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by John D Jaworski

4 Apr 2013
21 CFR 110.37(b)(3)

As source of contamination

Cited by John D Jaworski

4 Apr 2013
21 CFR 110.37(d)(3)

Self-closing doors

Cited by John D Jaworski

4 Apr 2013
21 CFR 110.37(e)

Running water at suitable temperature

Cited by John D Jaworski

Inspected site

LCLa Ceiba De Nicolya SANicoya, Costa Rica

Inspection team

JDJohn D Jaworski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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