FDA 483 - Delcon Srl - March 24, 2023

An FDA inspection of Delcon Srl, a medical device manufacturer based in Grassobbio, Bergamo, Italy, was conducted from March 20 to March 24, 2023. The inspection resulted in a Form FDA-483, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlighting two key observations regarding the firm's quality system.

The first observation cited inadequate procedures for complaint handling. Delcon Srl's complaint management process lacked clearly defined timeframes for investigation, leading to inconsistent completion periods that ranged from 30 to 120 days. This variability impacts the timely processing and resolution of customer feedback.

The second observation concerned deficiencies in the documentation of corrective and preventive action (CAPA) activities. A review of CAPA0074, which addressed issues with malfunctioning touch displays on certain separator models, revealed that not all relevant complaints were recorded and evaluated within the CAPA prior to its closure. Specifically, two additional complaints related to the same problem were identified that had not been included.

Delcon Srl has committed to correcting both observations. The firm is required to implement appropriate actions to resolve these non-conformities and ensure compliance with regulatory standards for medical device manufacturing.