Form 483

Colimex Inc Form 483, 2024-07-09

FDA issued a Form 483 to Colimex Inc on 2024-07-09 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Colimex Inc · Weslaco, United States · Issued July 9, 2024

Overview

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

9 Jul 2024
21 CFR 1.502(a)

Develop FSVP

Cited by Samuel S Cuevas

9 Jul 2024
21 CFR 1.504(a)

Hazard analysis written

Cited by Samuel S Cuevas

9 Jul 2024
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Samuel S Cuevas

Inspected site

CIColimex IncWeslaco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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