# FDA 483 - Ecotec Manufacturing, Inc. - April 20, 2023

Source: https://www.keypedia.com/records/483/ecotec-manufacturing-inc/134dd159-ed2c-4dfa-aa59-fff304f37daf

> FDA 483 for Ecotec Manufacturing, Inc. on April 20, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecotec Manufacturing, Inc.
- Inspection Date: 2023-04-20
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ecotec Manufacturing, Inc. in Okeechobee, FL, was inspected by the FDA from April 18-20, 2023. The inspection revealed two significant issues related to the firm's quality system, specifically concerning inadequate document control and a lack of established procedures for management review. These observations indicate deficiencies in the firm's operational and quality management processes.

## Related Documents

- [483 - 2019-06-26](https://www.keypedia.com/records/483/ecotec-manufacturing-inc/bc39acd1-4fec-493b-984e-2ea885abfc6f)
- [483 - 2026-02-05](https://www.keypedia.com/records/483/ecotec-manufacturing-inc/cf60b233-ca86-456f-a9cc-a0aee97def85)

## Related Officers

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

Company: https://www.keypedia.com/companies/ecotec-manufacturing-inc/aed1cd96-5e87-4417-aabe-db6d8ffb9c53

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