Drug factory · FDA FEI 3005947301

UCSF Radiopharmaceutical Facility

185 Berry Street Suite 350, San Francisco, CA, United States

Serious problems, FDA action at FDA's last inspection, Jul 24, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

3 drug inspections on record since 2015: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ammonia N-13	Makes it	UCSF Radiopharmaceutical Facility	24275-0385
Fludeoxyglucose F-18	Makes it	UCSF Radiopharmaceutical Facility	24275-0185
Gallium Ga-68 Gozetotide	Makes it	UCSF Radiopharmaceutical Facility	24275-0525

Ended	Result	Program	Problems noted
Jul 24, 2025	Serious problems, FDA action	Drug Quality Assurance	4
Jul 24, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 5, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	1

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 follow written quality assurance procedures.
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.
Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure that all key process parameters are controlled.
Conform to specs prior to release 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.

Lab written procedures 21 CFR 212.60(f)
Laboratory written procedures are not established to ensure that the lab equipment is routinely calibrated and maintained.

Registered with FDA for: positron emission tomography drug production.