Drug factory · FDA FEI 3006333738

Cyclotron Facility University of Pennsylvania

420 Curie Blvd, Philadelphia, PA, United States

No problems found at FDA's last inspection, Sep 10, 2025.

No Action Indicated: inspectors found no objectionable conditions.

3 drug inspections on record since 2014: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Fludeoxyglucose F-18	Makes it	Trustees of the University of Pennsylvania	40098-101

Ended	Result	Program	Problems noted
Sep 10, 2025	No problems found	Drug Quality Assurance	—
Jun 30, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	6
Mar 4, 2014	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Lack Adequate Resources, Facilities, Equipment. 21 CFR 212.10
You lack adequate resources to enable your personnel to perform their functions.
Examine, approve or reject 21 CFR 212.20(b)
You did not approve or reject components and in-process materials in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug.
Adverse effects of changes made 21 CFR 212.20(c)
You did not demonstrate that any change does not adversely affect the identity, strength, quality and purity of your PET drug.
Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch failed to meet specifications, you did not conduct an investigation and take appropriate corrective actions when necessary.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish written quality assurance procedures.
Equipment not suitable 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.

Registered with FDA for: api manufacture; positron emission tomography drug production.