# FDA 483 - Parfums Christian Dior - June 08, 2018

Source: https://www.globalkeysolutions.net/records/483/parfums-christian-dior/a955bdee-9f12-4bd8-b447-1e7ef258c1d2

> FDA 483 for Parfums Christian Dior on June 08, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parfums Christian Dior
- Inspection Date: 2018-06-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Parfums Christian Dior in St Jean de Braye, France, revealed significant deficiencies in their manufacturing of over-the-counter (OTC) drug products. The firm lacked adequate written procedures, process and equipment validation, and proper quality control oversight. Issues also included data integrity concerns, insufficient cleaning validation, and inadequate controls over components and rejected materials, indicating a broad failure to adhere to Good Manufacturing Practices.

## Related Documents

- [483 - 2014-06-13](https://www.globalkeysolutions.net/records/483/parfums-christian-dior/d9e2e878-99fb-4970-8ad8-b6e1d4ecb6ac)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/parfums-christian-dior/59c23185-69df-4e7d-a609-bd4b8ed2af94

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