FDA Inspection 1173082 — Ophtec USA, Inc.
The FDA completed an inspection of Ophtec USA, Inc. on Jun 24, 2022 in Sunrise, 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
- Jun 24, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Sunrise, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3046 | 21 CFR 812.150(b)(4) | No 6-month sponsor reports of current investigators |