Form 483

Colorado Biolabs Inc Form 483, 2026-02-11

FDA issued a Form 483 to Colorado Biolabs Inc on 2026-02-11 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Colorado Biolabs Inc · Cozad, United States · Issued February 11, 2026

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.

11 Feb 2026
21 CFR 111.205(b)(1)

Master manufacturing record - specifications, quality; packaging, labeling

Cited by Nia K Walker

11 Feb 2026
21 CFR 111.210

Master manufacturing record - record requirements

Cited by Nia K Walker

Inspected site

CBColorado Biolabs IncCozad, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.210Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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