Delcon SrlMarch 24, 2023

FDA 483 - Delcon Srl - March 24, 2023

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Record Details

An FDA inspection of Delcon Srl, a medical device manufacturer in Grassobbio, Italy, revealed two significant observations. The firm failed to adequately establish procedures for complaint handling, specifically regarding investigation timeframes. Additionally, corrective and preventive action activities were not fully documented, as not all relevant complaints were included in a CAPA prior to its closure.

Company: Delcon Srl
Inspection Date: March 24, 2023
Product Type: Device
Office: International Compliance Team
Person: Travis S. Bradley

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ID · ee1d44cb-c5ce-4261-b2ff-4e3c4e105058