Univar Solutions USA LLC
Form 483 issued October 29, 2024 · Morrisville, Pennsylvania
- Inspection
- Oct 21 – Oct 29, 2024
- Investigators
- Andrew C. Quintanilla· Elena M. Thomas· Nikolay Ayvazov
- Observations
- 4
- Pages
- 5
- FEI number
- 3002914735
In short: On October 29, 2024, FDA issued a Form 483 with 4 observations to Univar Solutions USA LLC in Morrisville, Pennsylvania (FEI 3002914735) after an inspection that ran Oct 21 – Oct 29, 2024. The investigators were Andrew C. Quintanilla, Elena M. Thomas and Nikolay Ayvazov. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 04
Individuals responsible for supervising the processing of a drug product lack the education, training, and experience…
This inspection in context
Andrew C. Quintanilla
1 document · 2024
Cites 211.142 (warehousing procedures) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmUnivar Solutions USA LLC 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 Univar Solutions USA LLC?
FDA listed 4 observations on this Form 483, mostly about materials, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Univar Solutions USA LLC?
Andrew C. Quintanilla, Elena M. Thomas and Nikolay Ayvazov are named on this Form 483, for the inspection of Oct 21 – Oct 29, 2024. Each investigator has a profile showing what they cite most.
When was Univar Solutions USA LLC inspected by FDA?
The inspection ran Oct 21 – Oct 29, 2024, and the Form 483 is dated October 29, 2024.
How do I get the full Form 483 for Univar Solutions USA 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.