# FDA 483 - Allison Medical, Inc. - July 29, 2022

Source: https://www.keypedia.com/records/483/allison-medical-inc/fd6b5d7a-a041-4189-b2bf-25bc86d12f0e

> FDA 483 for Allison Medical, Inc. on July 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allison Medical, Inc.
- Inspection Date: 2022-07-29
- Product Type: device
- Office Name: Denver District Office
- Summary: Allison Medical, Inc. in Littleton, CO, an importer of medical devices, was issued a Form FDA 483 with seven observations following an inspection. The firm demonstrated significant deficiencies in its quality system, including failures in reporting device recalls and serious injury events (MDRs) to the FDA. Additionally, procedures for complaint handling, corrective and preventive actions, supplier control, acceptance activities, and document control were found to be inadequately established.

## Related Documents

- [483 - 2023-04-28](https://www.keypedia.com/records/483/allison-medical-inc/72bffd14-66af-4809-a188-a6b78b6471fe)

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/allison-medical-inc/96ed5960-c7b7-48db-ab84-92ed398fc04c

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face