FDA Inspection 775537 — Focus Medical, LLC
The FDA completed an inspection of Focus Medical, LLC on Mar 29, 2012 in Bethel, CT. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2012
- Fiscal Year
- 2012
- 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 |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 5005 | 21 CFR 1002.11 | Failure to submit |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |