Estee Lauder N.V.
Form 483 issued April 26, 2024 · Oevel, Belgium
- Inspection
- Apr 22 – Apr 26, 2024
- Investigator
- Hung H. Do
- Observations
- 1
- Pages
- 3
- FEI number
- 1000224360
In short: On April 26, 2024, FDA issued a Form 483 with 1 observation to Estee Lauder N.V. in Oevel, Belgium (FEI 1000224360) after an inspection that ran Apr 22 – Apr 26, 2024. The investigator was Hung H. Do. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmEstee Lauder N.V. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Estee Lauder N.V.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Estee Lauder N.V.?
Hung H. Do is named on this Form 483, for the inspection of Apr 22 – Apr 26, 2024. Each investigator has a profile showing what they cite most.
When was Estee Lauder N.V. inspected by FDA?
The inspection ran Apr 22 – Apr 26, 2024, and the Form 483 is dated April 26, 2024.
How do I get the full Form 483 for Estee Lauder N.V.?
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.