# FDA 483 - Amerx Healthcare Corp - March 03, 2020

Source: https://www.keypedia.com/records/483/amerx-healthcare-corp/17890f54-86e2-43b0-8512-1c41d6e607f1

> FDA 483 for Amerx Healthcare Corp on March 03, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Amerx Healthcare Corp
- Inspection Date: 2020-03-03
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Amerx Healthcare Corp, a medical device kit assembler/warehouse in Clearwater, FL, was cited for three significant quality system deficiencies during an FDA inspection. These issues include a failure to implement written Medical Device Reporting (MDR) procedures and report adverse events, inadequately established quality audit procedures, and unmaintained document control procedures related to management reviews.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/amerx-healthcare-corp/8aca1c81-0d12-4398-98b6-c216bf73109a

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