# FDA 483 - Invotec International Inc. - November 04, 2021

Source: https://www.globalkeysolutions.net/records/483/invotec-international-inc/aedf0a23-e900-4597-8844-174681aecb88

> FDA 483 for Invotec International Inc. on November 04, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Invotec International Inc.
- Inspection Date: 2021-11-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA Form 483 was issued to Invotec International Inc. in Jacksonville, FL, following an inspection of their medical device manufacturing facility. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning complaint investigations, incoming product acceptance procedures, and supplier management. These issues indicate a lack of adequate controls to ensure device quality and compliance with regulatory requirements.

## Related Documents

- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/invotec-international-inc/a2655126-9ede-4f40-be54-644d4cc4e3fa)

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6