# FDA 483 - Cefla s.c - July 20, 2018

Source: https://www.globalkeysolutions.net/records/483/cefla-sc/c416adcc-1747-4053-b8ab-b3eec7f1a0e2

> FDA 483 for Cefla s.c on July 20, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cefla s.c
- Inspection Date: 2018-07-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Cefla s.c, a manufacturer in Verona, Italy, was inspected by the FDA from July 9-20, 2018. The inspection revealed that the firm failed to adequately document design verification results in the design history file. This indicates a deficiency in their quality system regarding design controls.

## Related Documents

- [483 - 2018-07-09](https://www.globalkeysolutions.net/records/483/cefla-sc/59cc3e9f-736c-4e3b-a7ce-afc533a5b183)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.globalkeysolutions.net/companies/cefla-sc/4ea6979f-a3a2-48a8-b16c-fe254a5663b0

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