Celfa s.c.July 20, 2018

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

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Record Details

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.

Company: Celfa s.c.
Inspection Date: July 20, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jennifer S. Ness (investigator)

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ID · 73d48240-2a8b-4daa-9e1e-6e0a5a7ea4cb