# FDA 483 - Inspirx, Inc. - March 11, 2019

Source: https://www.globalkeysolutions.net/records/483/inspirx-inc/f48e2894-9145-46aa-977b-8aecdbcca2b5

> FDA 483 for Inspirx, Inc. on March 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inspirx, Inc.
- Inspection Date: 2019-03-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Inspirx, Inc. in Somerset, NJ was cited during an FDA inspection from March 5-11, 2019, for significant deficiencies in its complaint handling system for medical devices. The firm failed to adequately review, evaluate, and investigate complaints, often closing them prematurely without complete investigations from contract manufacturers. Additionally, complaint files lacked documented test results for functional testing.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gobiga-vanniyasingam/db801a84-a834-4439-9a0a-c37032c95317)

Company: https://www.globalkeysolutions.net/companies/inspirx-inc/0da449a2-714b-4792-a8c7-b5ba059488c0

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248