# FDA 483 - EOSolutions Corp - December 07, 2023

Source: https://www.keypedia.com/records/483/eosolutions-corp/19c789f8-d2b9-46a1-965a-6aacb6e9e5cb

> FDA 483 for EOSolutions Corp on December 07, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EOSolutions Corp
- Inspection Date: 2023-12-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: EOSolutions Corp in Miramar, FL, a specification developer of percutaneous catheter devices, was cited for two significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for quality audits, including issues with a third-party auditor and delayed audit reports. Additionally, the company's training procedures were found to be inadequate, specifically regarding a sales and marketing employee who handled complaints without proper training.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/eosolutions-corp/34a2a3a5-a75d-49bc-9ae5-0adcc0159c13

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6