# FDA 483 - Aea Srl - January 10, 2020

Source: https://www.keypedia.com/records/483/aea-srl/e6c6bd6b-78b3-40e6-910d-8ba804b2ff77

> FDA 483 for Aea Srl on January 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aea Srl
- Inspection Date: 2020-01-10
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of A.E.A Srl, a device manufacturer in Moie de Maiolati, Italy, identified two significant issues. The firm's Device History Records did not consistently demonstrate manufacturing in accordance with the device master record, specifically regarding negative pressure specifications. Additionally, Service Reports were found to be inadequately documented, lacking reasons for service calls and sufficient detail on activities performed.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/aea-srl/7e4f0246-4e69-460c-ae03-9110ddcd9883

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