# FDA 483 - Ecotec Manufacturing, Inc. - February 05, 2026

Source: https://www.keypedia.com/records/483/ecotec-manufacturing-inc/cf60b233-ca86-456f-a9cc-a0aee97def85

> FDA 483 for Ecotec Manufacturing, Inc. on February 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecotec Manufacturing, Inc.
- Inspection Date: 2026-02-05
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Ecotec Manufacturing, Inc. in Okeechobee, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for corrective and preventive actions (CAPA), specifically lacking root cause analysis procedures. Additionally, the firm failed to adequately maintain complaint handling records and records of reworked medical devices.

## Related Documents

- [483 - 2019-06-26](https://www.keypedia.com/records/483/ecotec-manufacturing-inc/bc39acd1-4fec-493b-984e-2ea885abfc6f)
- [483 - 2023-04-20](https://www.keypedia.com/records/483/ecotec-manufacturing-inc/134dd159-ed2c-4dfa-aa59-fff304f37daf)

## 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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9