483
Bionen S.r.l.Bionen S.r.l. – FDA 483, Feb 20, 2020
Record Details
Bionen S.A.S. in Firenze, Italy, received two observations during an FDA inspection concerning the manufacturing of medical devices, specifically needle electrodes for Botox injection. The inspection revealed deficiencies in adequately validating the sensor assembly and pouch sealing processes, as well as failures in establishing adequate procedures for investigating and evaluating complaints for MDR reportability.
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ID · 46a6e600-3a82-4e2c-bdc1-d6ec408068c5
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