FDA Inspection 711375 — Primo Medical Group
The FDA completed an inspection of Primo Medical Group on Feb 18, 2011 in Stoughton, MA. 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
- Feb 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Stoughton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |