# FDA 483 - SAFC, Inc. - April 25, 2014

Source: https://www.keypedia.com/records/483/safc-inc/e6b42d2e-8df7-40f8-96c0-151fea57e430

> FDA 483 for SAFC, Inc. on April 25, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SAFC, Inc.
- Inspection Date: 2014-04-25
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: SAFC, Inc., a contract device manufacturer in Madison, WI, was cited with three observations during an FDA inspection. The inspection revealed deficiencies in establishing adequate equipment maintenance schedules, controlling nonconforming products, and implementing effective corrective and preventive action procedures. These issues indicate a need for improvements in their quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/safc-inc/8b9b439f-c427-4b43-85d2-81ce982736be

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