# FDA 483 - Epic Systems Corporation - December 12, 2014

Source: https://www.globalkeysolutions.net/records/483/epic-systems-corporation/86756add-1849-4ab4-8999-f651bd40a988

> FDA 483 for Epic Systems Corporation on December 12, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Epic Systems Corporation
- Inspection Date: 2014-12-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Epic Systems Corporation, a medical device firm in Verona, WI, was inspected by the FDA from December 1 to December 12, 2014. The inspection revealed issues primarily related to the firm's quality system, specifically concerning the maintenance of complaint files and the establishment of adequate procedures for management review and corrective and preventive actions. These observations indicate deficiencies in the firm's adherence to quality system regulations for medical devices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/corey-k-reno/f6ff7629-784b-467b-8b5b-2625779d1c1e)

Company: https://www.globalkeysolutions.net/companies/epic-systems-corporation/5dbf8143-aad1-4905-a58d-5f9ab7abe1cb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d