FDA Inspection 1074330 — Hamamatsu/Queen's PET Imaging Center, LLC
The FDA completed an inspection of Hamamatsu/Queen's PET Imaging Center, LLC on Dec 13, 2018 in Honolulu, HI. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17775 | 21 CFR 212.40(c) | Each lot identified and tested |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17859 | 21 CFR 212.60(g) | Test records complete (general) |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |