FDA Inspection 855279 — Hamamatsu/Queen's PET Imaging Center, LLC
The FDA completed an inspection of Hamamatsu/Queen's PET Imaging Center, LLC on November 8, 2013 in Honolulu, HI. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 167 | 21 CFR 606.170(b) | Adverse reaction - fatality |