Form 483

SGS North America Inc. Form 483, 2026-06-09

FDA issued a Form 483 to SGS North America Inc. on 2026-06-09 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

SGS North America Inc. · Fairfield, United States · Issued June 9, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Jun 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Janet A Rajan, Stephenie M Ortiz, Suchan Kim

Inspected site

SNSGS North America Inc.Fairfield, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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