SGS North America Inc.
Form 483 issued March 20, 2026 · Lincolnshire, Illinois
- Inspection
- Mar 17 – Mar 20, 2026
- Investigators
- Gabriel Bermudez-Picart· Michele L. Glendenning
- Observations
- 1
- Pages
- 4
- FEI number
- 1418028
In short: On March 20, 2026, FDA issued a Form 483 with 1 observation to SGS North America Inc. in Lincolnshire, Illinois (FEI 1418028) after an inspection that ran Mar 17 – Mar 20, 2026. The investigators were Gabriel Bermudez-Picart and Michele L. Glendenning. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Gabriel Bermudez-Picart
3 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
The firmSGS North America Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SGS North America Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected SGS North America Inc.?
Gabriel Bermudez-Picart and Michele L. Glendenning are named on this Form 483, for the inspection of Mar 17 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was SGS North America Inc. inspected by FDA?
The inspection ran Mar 17 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for SGS North America Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.