Univar Solutions, LLC
Form 483 issued April 12, 2024 · Commerce, California
- Inspection
- Apr 8 – Apr 12, 2024
- Investigator
- Carolina D. Vasquez
- Observations
- 4
- Pages
- 4
- FEI number
- 2015184
In short: On April 12, 2024, FDA issued a Form 483 with 4 observations to Univar Solutions, LLC in Commerce, California (FEI 2015184) after an inspection that ran Apr 8 – Apr 12, 2024. The investigator was Carolina D. Vasquez. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 03
Your master production and control records for each drug product were not independently checked, dated, and…
- 04
A written record of the program along with appropriate validation data has not been maintained in…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmUnivar Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Univar Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Univar Solutions, LLC?
Carolina D. Vasquez is named on this Form 483, for the inspection of Apr 8 – Apr 12, 2024. Each investigator has a profile showing what they cite most.
When was Univar Solutions, LLC inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2024, and the Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Univar Solutions, 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.