# FDA 483 - Laboratoires Urgo - December 14, 2017

Source: https://www.keypedia.com/records/483/laboratoires-urgo/bf4fd0bf-e331-4611-a8d2-13231a7df763

> FDA 483 for Laboratoires Urgo on December 14, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratoires Urgo
- Inspection Date: 2017-12-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Laboratoires Urgo, a manufacturer in Chevigny St Sauveur, France, revealed three significant observations. The firm was cited for inadequate process validation, deficiencies in its corrective and preventive action (CAPA) procedures, and insufficient documentation of design outputs prior to release. These issues indicate a need for improved quality system controls.

## Related Documents

- [483 - 2017-12-11](https://www.keypedia.com/records/483/laboratoires-urgo/a4aeb48b-5a6e-4e8a-9cfd-5ff309770d0c)

## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.keypedia.com/companies/laboratoires-urgo/778edcaf-341c-48fe-939c-c5ddb29b12b8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd