FDA Inspection 1195261 — AxioMed, LLC.
The FDA completed an inspection of AxioMed, LLC. on Jan 13, 2023 in Malden, 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
- Jan 13, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Malden, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |