# FDA 483 - General Medical Company - July 23, 2019

Source: https://www.globalkeysolutions.net/records/483/general-medical-company/841575f7-3df0-459d-be5d-50ff788b3692

> FDA 483 for General Medical Company on July 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: General Medical Company
- Inspection Date: 2019-07-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected General Medical Company, a medical device manufacturer in Jacksonville, FL, and identified seven significant quality system deficiencies. These included inadequate procedures for Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and process validation. The firm also failed to maintain proper records for device history, acceptance activities, and service reports, with many issues being repeat observations from a previous inspection and cited in a Warning Letter.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/general-medical-company/ac000c8a-6681-4ce4-a6dd-513dd7bdd7b1

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