FDA Inspection 1203700 — Ecotec Manufacturing, Inc.
The FDA completed an inspection of Ecotec Manufacturing, Inc. on April 20, 2023 in Okeechobee, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Okeechobee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |