# FDA 483 - Delcon Srl - March 24, 2023

Source: https://www.keypedia.com/records/483/delcon-srl/ee1d44cb-c5ce-4261-b2ff-4e3c4e105058

> FDA 483 for Delcon Srl on March 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delcon Srl
- Inspection Date: 2023-03-24
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/delcon-srl/2978f41c-0073-497b-b510-27349c16008d

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321