# FDA 483 - Ecotec Manufacturing, Inc. - June 26, 2019

Source: https://www.keypedia.com/records/483/ecotec-manufacturing-inc/bc39acd1-4fec-493b-984e-2ea885abfc6f

> FDA 483 for Ecotec Manufacturing, Inc. on June 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecotec Manufacturing, Inc.
- Inspection Date: 2019-06-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ecotec Manufacturing, Inc. in Okeechobee, FL, a medical device manufacturer, was inspected by the FDA from June 24-26, 2019. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls, process validation, purchasing controls, and complaint handling. These issues indicate a pervasive lack of established procedures and documentation for critical aspects of medical device manufacturing.

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## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

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