# FDA 483 - eCordum, Inc. - July 12, 2023

Source: https://www.keypedia.com/records/483/ecordum-inc/282bea24-b342-436f-bdc9-4d1e11013d13

> FDA 483 for eCordum, Inc. on July 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: eCordum, Inc.
- Inspection Date: 2023-07-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of eCordum, Inc. in Amherst, MA, a medical device specification designer, revealed numerous significant deficiencies in its quality system. The firm lacks established procedures and documentation for critical areas including medical device reporting, corrective and preventive actions, complaint handling, and various stages of design control. These observations indicate a fundamental absence of a robust quality management system for medical device development.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/ecordum-inc/55dca54f-9911-4dcd-b7ec-1e811d84c413

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961