FDA Inspection 1210101 — ISOThrive, Inc.
The FDA completed an inspection of ISOThrive, Inc. on June 30, 2023 in Healdsburg, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 30, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Healdsburg, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |