Solesence, Inc.
Form 483 issued January 9, 2026 · Romeoville, Illinois
- Inspection
- Jan 6 – Jan 9, 2026
- Investigators
- Kelly M. Bromley· Tyler Peterson
- Observations
- 1
- Pages
- 2
- FEI number
- 3003574860
In short: On January 9, 2026, FDA issued a Form 483 with 1 observation to Solesence, Inc. in Romeoville, Illinois (FEI 3003574860) after an inspection that ran Jan 6 – Jan 9, 2026. The investigators were Kelly M. Bromley and Tyler Peterson. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Processes for the production of API are…
This inspection in context
Kelly M. Bromley
4 documents · 2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmSolesence, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solesence, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Solesence, Inc.?
Kelly M. Bromley and Tyler Peterson are named on this Form 483, for the inspection of Jan 6 – Jan 9, 2026. Each investigator has a profile showing what they cite most.
When was Solesence, Inc. inspected by FDA?
The inspection ran Jan 6 – Jan 9, 2026, and the Form 483 is dated January 9, 2026.
How do I get the full Form 483 for Solesence, 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.