# FDA 483 - Atos Medical Inc - December 12, 2018

Source: https://www.globalkeysolutions.net/records/483/atos-medical-inc/6fe49d3e-0ecf-4bba-b18a-f179f733276c

> FDA 483 for Atos Medical Inc on December 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atos Medical Inc
- Inspection Date: 2018-12-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Atos Medical Inc., a medical device manufacturer, received an FDA Form 483 citing significant quality system deficiencies during an inspection in New Berlin, WI. Observations included a lack of established procedures for reworking nonconforming products, inadequate documentation of corrective and preventive actions, and failure to justify not reporting correction/removal actions to the FDA. The firm also lacked documented personnel training records.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.globalkeysolutions.net/companies/atos-medical-inc/a9853c86-45a1-4144-8eb2-34f7504b5510

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