# FDA 483 - Arjo, Inc. dba ArjoHuntleigh - December 02, 2021

Source: https://www.globalkeysolutions.net/records/483/arjo-inc-dba-arjohuntleigh/07a59ee6-5179-4e7e-94fe-46fb7bda9e52

> FDA 483 for Arjo, Inc. dba ArjoHuntleigh on December 02, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arjo, Inc. dba ArjoHuntleigh
- Inspection Date: 2021-12-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: Arjo, Inc. dba ArjoHuntleigh, a medical device importer in Addison, IL, was cited for deficiencies in its complaint handling procedures during an FDA inspection. The firm's global procedures were found to be inconsistent with local instructions, and evaluations for Medical Device Reports (MDRs) were not adequately conducted or documented within required timeframes. This indicates a significant issue with their quality system regarding post-market surveillance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/arjo-inc-dba-arjohuntleigh/5e42c243-af70-49a4-ba55-80c8f72482a7

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669