FDA Inspection 1240289 — Synchronis Medical Llc
The FDA completed an inspection of Synchronis Medical Llc on Jun 4, 2024 in Romulus, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 4, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Romulus, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |