Form 483

Swiss Bio Colostrum AG Form 483, 2026-04-10

FDA issued a Form 483 to Swiss Bio Colostrum AG on 2026-04-10 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Swiss Bio Colostrum AG · Cham, Switzerland · Issued April 10, 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.

10 Apr 2026
21 CFR 111.205(a)

Master manufacturing record - prepared

Cited by Moraima J Ramos-Valle

10 Apr 2026
21 CFR 111.70(e)

Specifications - finished dietary supplement

Cited by Moraima J Ramos-Valle

Inspected site

SBSwiss Bio Colostrum AGCham, Switzerland

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)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