FDA Inspection 1220841 — OPTIMOTION IMPLANTS LLC
The FDA completed an inspection of OPTIMOTION IMPLANTS LLC on Oct 20, 2023 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 20, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |