FDA Inspection 810210 — Delcath Systems Inc.
The FDA completed an inspection of Delcath Systems Inc. on Nov 29, 2012 in New York, NY. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |