Drug factory · FDA FEI 2971884
Hamamatsu/Queens PET Imaging Center, LLC
1301 Punchbowl Street, Honolulu, HI, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 11, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | Hamamatsu/Queen’s PET Imaging Center, LLC | 76376-618 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 11, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| May 14, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 11, 2024 inspection
- Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation and take appropriate corrective actions when necessary. - Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Supplies adequately controlled 21 CFR 212.60(d)
Your identity, purity and quality of reagents, solutions and supplies used in your testing procedures are not adequately controlled.
Dec 13, 2018 inspection
- Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Each lot identified and tested 21 CFR 212.40(c)
Each lot of containers and closures is not uniquely identified. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. - Test records complete (general) 21 CFR 212.60(g)
Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays.
Registered with FDA for: positron emission tomography drug production.