# FDA 483 - Invotec International Inc. - February 05, 2019

Source: https://www.globalkeysolutions.net/records/483/invotec-international-inc/a2655126-9ede-4f40-be54-644d4cc4e3fa

> FDA 483 for Invotec International Inc. on February 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Invotec International Inc.
- Inspection Date: 2019-02-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Invotec International Inc. in Jacksonville, FL, a medical device manufacturer, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed deficiencies in process validation, monitoring of process parameters, corrective and preventive actions, purchasing controls, and device history record maintenance. These issues indicate a lack of adequate quality system procedures for manufacturing and controlling medical devices.

## Related Documents

- [483 - 2021-11-04](https://www.globalkeysolutions.net/records/483/invotec-international-inc/aedf0a23-e900-4597-8844-174681aecb88)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)

Company: https://www.globalkeysolutions.net/companies/invotec-international-inc/620c6dc4-b247-430b-af45-15fba1fd7fd4

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