FDA Inspection 944715 — Wavelight GmbH
The FDA completed an inspection of Wavelight GmbH on Sep 11, 2015 in Pressath. 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
- Sep 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pressath (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |