Atlas

Form 483

Alimentos Kamuk Internacional (Costa Rica) S. A. Form 483, 2019-06-04

FDA issued a Form 483 to Alimentos Kamuk Internacional (Costa Rica) S. A. on 2019-06-04 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Alimentos Kamuk Internacional (Costa Rica) S. A. · Paraiso, Costa Rica · Issued June 4, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Jun 2019
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by Joseph T Frost

4 Jun 2019
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Joseph T Frost

Inspected site

AKAlimentos Kamuk Internacional (Costa Rica) S. A.Paraiso, Costa Rica

Inspection team

JTJoseph T Frost

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.100(b)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 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