# FDA 483 - Estee Lauder N.V. - April 26, 2024

Source: https://www.keypedia.com/records/483/estee-lauder-nv/531b8974-ef1d-4fac-96a8-c0edfb27f68b

> FDA 483 for Estee Lauder N.V. on April 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Estee Lauder N.V.
- Inspection Date: 2024-04-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Estee Lauder N.V., an OTC drug manufacturer in Oevel, Belgium, from April 22-26, 2024, identified a significant deficiency in their quality control. The firm's quality unit failed to adequately test incoming high-risk drug components for impurities. This lapse raises concerns about the purity and safety of OTC drug products manufactured and distributed to the U.S. market.

## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/estee-lauder-nv/c610c6c6-b0ee-4ffa-bae9-1ae79b7dfa38

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1