# FDA 483 - Avotec, Inc. - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/avotec-inc/a162456e-d825-4085-a6fc-94771d653e31

> FDA 483 for Avotec, Inc. on January 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avotec, Inc.
- Inspection Date: 2023-01-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Avotec, Inc. in Stuart, FL, was inspected by the FDA from January 23-27, 2023, regarding its manufacturing operations for class 2 medical devices. The inspection revealed significant deficiencies in the firm's quality system, including inadequate complaint handling records, lack of documented employee training requirements, and a failure to conduct required quality audits. One observation was a repeat from a previous inspection, indicating persistent issues.

## Related Officers

- [Alex J. Wild](https://www.globalkeysolutions.net/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.globalkeysolutions.net/companies/avotec-inc/c9e64cf4-dc73-4c66-b692-3ef7516ed465

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