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

Source: https://www.keypedia.com/records/483/celfa-sc/73d48240-2a8b-4daa-9e1e-6e0a5a7ea4cb

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

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## Details

- Record Type: 483
- Company Name: Celfa s.c.
- Inspection Date: 2018-07-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Gifa S.C. in Verona, Italy, was inspected by the FDA from July 12-20, 2018. The inspection revealed one observation regarding inadequate procedures for the acceptance and control of in-process products. Specifically, failing test results for a beam limiter sub-assembly were not retained within the device history record or properly referenced.

## Related Officers

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

Company: https://www.keypedia.com/companies/celfa-sc/22da8ec0-ed7f-46f0-b149-cc6e7b11ebc8

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