Form 483

Co Fu Business Company, Ltd. Form 483, 2025-06-24

FDA issued a Form 483 to Co Fu Business Company, Ltd. on 2025-06-24 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Co Fu Business Company, Ltd. · New Taipei City, Taiwan · Issued June 24, 2025

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.

24 Jun 2025
21 CFR 117.135(a)(1)

Sanitation preventive controls - Identify (Written)

Cited by Gale L Glinecki

24 Jun 2025
21 CFR 117.410(c)

Supply-chain program - Assurance (Adequate)

Cited by Gale L Glinecki

Inspected site

CFCo Fu Business Company, Ltd.New Taipei City, Taiwan

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.410(c)Cited 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