# Aspen Imaging Healthcare, Inc – FDA 483

Source: https://www.keypedia.com/records/483/aspen-imaging-healthcare-inc/cce46341-18ed-4602-978c-8c4fedbe2290

> FDA 483 for Aspen Imaging Healthcare, Inc on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen Imaging Healthcare, Inc
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Aspenstate, Inc., a medical device manufacturer, received a Form FDA 483 with ten observations following an inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate controls for incoming product, process controls, nonconforming product, and equipment calibration. Additional issues involved insufficient employee training, incomplete device history records, non-compliance with UDI requirements, and the absence of an appointed management representative.

## Related Officers

- [investigator](https://www.keypedia.com/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.keypedia.com/companies/aspen-imaging-healthcare-inc/739a0afe-02e5-4861-9ffb-00783d7b229b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab