# FDA 483 - ActiGraph, LLC - July 30, 2015

Source: https://www.keypedia.com/records/483/actigraph-llc/15e9a66a-89b3-4a2b-a6c3-99beadabba65

> FDA 483 for ActiGraph, LLC on July 30, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ActiGraph, LLC
- Inspection Date: 2015-07-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Actigraph, LLC in Pensacola, FL, a medical device specification developer, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in complaint handling, design validation, corrective and preventive action documentation, and quality audit procedures. These issues indicate a need for improved quality system controls to ensure compliance.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)

Company: https://www.keypedia.com/companies/actigraph-llc/027aa9e0-5f9e-4439-8c83-fdbaebbbe2ae

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6