FDA Inspection 639147 — PATH
The FDA completed an inspection of PATH on Jan 26, 2010 in Seattle, WA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |