FDA Inspection 1166861 — Fundus Photo, LLC
The FDA completed an inspection of Fundus Photo, LLC on Apr 12, 2022 in Saint Louis, MO. 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
- Apr 12, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |