# FDA 483 - Case Medical, Inc. - October 12, 2023

Source: https://www.keypedia.com/records/483/case-medical-inc/3e79e9b1-fbe3-476a-96e4-f6b72b8f4126

> FDA 483 for Case Medical, Inc. on October 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Case Medical, Inc.
- Inspection Date: 2023-10-12
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Case Medical, Inc. in Bloomfield, NJ, a medical device manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish and close corrective and preventive actions in a timely manner, maintain supplier requirements, and implement an adequate risk analysis procedure. These issues indicate a systemic breakdown in ensuring product quality and safety.

## Related Officers

- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)

Company: https://www.keypedia.com/companies/case-medical-inc/031b077c-18aa-444a-b4da-7ca746875c8d

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