FDA Inspection 1023481 — OPTINOSE US INC
The FDA completed an inspection of OPTINOSE US INC on May 26, 2017 in Yardley, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Yardley, PA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |