Solventum US LLC
Form 483 issued September 6, 2024 · Columbia, Missouri
- Inspection
- Sep 3 – Sep 6, 2024
- Investigators
- Geoffrey K. Kilili· Jacob G. Lutz
- Observations
- 2
- Pages
- 3
- FEI number
- 3003399824
In short: On September 6, 2024, FDA issued a Form 483 with 2 observations to Solventum US LLC in Columbia, Missouri (FEI 3003399824) after an inspection that ran Sep 3 – Sep 6, 2024. The investigators were Geoffrey K. Kilili and Jacob G. Lutz. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.166(a)(3) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written stability program for ding products does not include reliable, meaningfill…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Geoffrey K. Kilili
7 documents · 2021–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmSolventum US LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solventum US LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Solventum US LLC?
Geoffrey K. Kilili and Jacob G. Lutz are named on this Form 483, for the inspection of Sep 3 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was Solventum US LLC inspected by FDA?
The inspection ran Sep 3 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Solventum US LLC?
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.