# FDA 483 - EHOB, Inc. - May 06, 2019

Source: https://www.keypedia.com/records/483/ehob-inc/0d211afb-8849-47df-8615-68f5bb88455a

> FDA 483 for EHOB, Inc. on May 06, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EHOB, Inc.
- Inspection Date: 2019-05-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: EHOB, Inc. in Indianapolis, IN, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately validate its welding processes, establish consistent complaint handling procedures, and implement proper Medical Device Reporting (MDR) protocols. These issues indicate a lack of robust controls over manufacturing processes, complaint management, and regulatory reporting requirements.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.keypedia.com/companies/ehob-inc/24c28d3b-ade2-4a93-a4a9-ef7570c34a03

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0