FDA Inspection 1271132 — Focus Medical, LLC
The FDA completed an inspection of Focus Medical, LLC on May 2, 2025 in Bethel, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 2, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bethel, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5208 | 21 CFR 1040.11(a)(2) | Calibration of measurement system |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |