Solesence, Inc.
Form 483 issued April 13, 2023 · Romeoville, Illinois
- Inspection
- Apr 13, 2023
- Investigator
- Peng Zhou
- Observations
- 2
- Pages
- 3
- FEI number
- 3003574860
In short: On April 13, 2023, FDA issued a Form 483 with 2 observations to Solesence, Inc. in Romeoville, Illinois (FEI 3003574860) after an inspection that ran Apr 13, 2023. The investigator was Peng Zhou. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
For the release testing of Zinc Oxide Finished Products and Zinc Oxide API, there are no…
- 02
You purchase (A) ‘to manufacture coated Zinc Oxide Powder {ZL…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solesence, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Solesence, Inc.?
Peng Zhou is named on this Form 483, for the inspection of Apr 13, 2023. Each investigator has a profile showing what they cite most.
When was Solesence, Inc. inspected by FDA?
The inspection ran Apr 13, 2023, and the Form 483 is dated April 13, 2023.
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.