# FDA 483 - Leventon S. A. U. - March 22, 2018

Source: https://www.globalkeysolutions.net/records/483/leventon-s-a-u/ddfbd10f-2a49-44d1-934e-a308aadbee0e

> FDA 483 for Leventon S. A. U. on March 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Leventon S. A. U.
- Inspection Date: 2018-03-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Leventon S. A. U., a device manufacturer in Sant Esteve Sesrovires, Spain, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, lacked validation for critical manufacturing processes, and did not submit required Medical Device Reports (MDRs) for device malfunctions. Additionally, issues were noted with design change procedures, process controls, and acceptance criteria for in-process product.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/leventon-s-a-u/524a4a3e-36d6-4e4f-b6c8-59b577f87b00

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