Drug factory · FDA FEI 3004971261

The Feinstein Institutes for Medical Research

350 Community Drive, Manhasset, NY, United States

Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Fluorodopa F-18	Makes it	The Feinstein Institutes for Medical Research	13267-345, 13267-346

Ended	Result	Program	Problems noted
May 9, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 25, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jan 19, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 9, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish written quality assurance procedures.
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.

Supplies adequately controlled 21 CFR 212.60(d)
Your supplies used in your testing procedures are not adequately controlled.
Equipment 21 CFR 212.60(e)
All equipment used to perform the testing is not capable of producing valid results.
Complete record of all laboratory test data 21 CFR 212.60(g)(3)
Laboratory records did not contain a complete record of all data obtained in the course of each test.

Registered with FDA for: positron emission tomography drug production.