FDA Inspection 1246341 — Microbiome Health Research Institute
The FDA completed an inspection of Microbiome Health Research Institute on Aug 14, 2024 in Woburn, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Woburn, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7635 | 21 CFR 312.7(b) | Commercial distribution of an investigational drug |