Form 483

COTIJA AVOCADOS LLC Form 483, 2024-10-15

FDA issued a Form 483 to COTIJA AVOCADOS LLC on 2024-10-15 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

COTIJA AVOCADOS LLC · Baytown, United States · Issued October 15, 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.

15 Oct 2024
21 CFR 1.502(a)

Develop FSVP

Cited by Storm Vancuso

15 Oct 2024
21 CFR 1.512(c)(1)(i)

Small foreign supplier compliance

Cited by Storm Vancuso

15 Oct 2024
21 CFR 1.512(c)(3)(i)

Written procedures - establish, unapproved supplier

Cited by Storm Vancuso

Inspected site

CACOTIJA AVOCADOS LLCBaytown, 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 1.512(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.512(c)(3)(i)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