> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# UCSF Radiopharmaceutical Facility CGMP Issues
- URL: https://www.fdaweb.com/ucsf-radiopharmaceutical-facility-cgmp-issues/
- Published: 2026-04-21T12:00:00.000Z
- Updated: 2026-09-14T13:37:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161013

A 7/21-7/24/2026 FDA inspection at the University of California at San Francisco (UCSF) radiopharmaceutical drug manufacturing facility in San Francisco, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ucsf-radiopharmaceutical-facility-719568-04132026?ref=fdaweb.com) says the specific violations were:

- failure to conduct adequate investigations and take appropriate corrective action when a failure of a product batch or any component of the batch failed to meet any of its specifications;
- failure to follow written quality assurance procedures; and
- failure to adequately follow procedures to ensure that all equipment is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results.

FDA recommends the facility engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The letter also says UCSF failed to submit Field Alert Reports upon discovery of a product quality defect.

The UCSF radiopharmaceutical facility was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.