FDA Inspection 1303440 — Ecotec Manufacturing, Inc.
The FDA completed an inspection of Ecotec Manufacturing, Inc. on February 5, 2026 in Okeechobee, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Okeechobee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23248 | ISO 13485:2016 Clause 8.3.4 | Rework records not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |