Drug factory · FDA FEI 3029514624
Pharmalogic New York City, LLC
390 Concord Ave, Bronx, NY, United States
Serious problems, FDA action at FDA's last inspection, Aug 19, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
1 drug inspection on record since 2026: 0 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | Precision Nuclear LLC | 52768-001 |
| Flurpiridaz F-18 | Makes it | GE Healthcare Inc. | 0407-8787 |
| Flutemetamol F-18 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
| Piflufolastat F-18 | Makes it | Aphelion LLC, Progenics Pharmaceuticals, Inc. | 85347-001, 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 19, 2026 | Serious problems, FDA action | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 19, 2026 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 take appropriate corrective actions when necessary.
Registered with FDA for: positron emission tomography drug production.