CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to UCSF Radiopharmaceutical Facility, 2026-04-13
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
FDA issued a Warning Letter to UCSF Radiopharmaceutical Facility on 2026-04-13 citing: CGMP/Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ucsf-radiopharmaceutical-facility-719568-04132026
Argus analysis
UCSF Radiopharmaceutical Facility (MARCS-CMS 719568, FEI 3005947301) received an FDA Warning Letter dated April 13, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Finished Pharmaceuticals/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on April 21, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER UCSF Radiopharmaceutical Facility MARCS-CMS 719568 — April 13, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-62 Product: Drugs Recipient: Recipient Name Dr. Robin C. Cumming Recipient Title Director, Radiopharmaceutical Facility UCSF Radiopharmaceutical Facility 185 Berry St. Ste. 350 San Francisco , CA 94107-9107 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-62 April 13, 2026 Dear Dr. Cumming: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, UCSF Radiopharmaceutical Facility, FEI 3005947301, at 185 Berry St. Ste. 350, San Francisco, from July 21 to 24, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for (b)(4) drugs. See Title 21 Code of Federal Regulations (CFR), part (b)(4) (21 CFR part (b)(4) ). Because your methods, facilities, or controls for manufacturing, processing, packaging, or holding do not conform to CGMP, your (b)(4) drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your August 14, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications. (21 CFR (b)(4)). You manufacture (b)(4) drug products for (b)(4) administration. Your investigations into multiple failing sterility test results were inadequate. From 2022 to 2023, you initiated multiple investigations into sterility test failures for batches of (b)(4) injection and concluded that the probable root cause was contamination by the operator during sampling of the finished product vial. However, your investigations did not adequately support this root cause. For example, you opened a sterility failure investigation on April 3, 2023, after your analyst reported turbidity in the (b)(4) tube during incubation of your sterility sample for a batch of (b)(4) for injection. The recovered microorganism was identified as Bacillus species, a gram-positive spore-forming bacterium. Although no conclusive laboratory testing errors were found, your investigation postulated that the batch of (b)(4) was contaminated with the bacteria during sterility testing. You invalidated the sterility test result based on your flawed assumption that the organism also should have grown in the (b)(4) tube. Your firm failed to thoroughly evaluate whether this and other batch sterility test failures were caused by deficient aseptic man…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has UCSF Radiopharmaceutical Facility had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for UCSF Radiopharmaceutical Facility as of 2026-04-21. Argus ingests new FDA enforcement records daily.
- What FDA violations was UCSF Radiopharmaceutical Facility cited for?
- The FDA Warning Letter to UCSF Radiopharmaceutical Facility (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to UCSF Radiopharmaceutical Facility, 2026-04-13. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ucsf-radiopharmaceutical-facility-2026-04-13-cgmp
"CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to UCSF Radiopharmaceutical Facility, 2026-04-13." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ucsf-radiopharmaceutical-facility-2026-04-13-cgmp.
Argus HQ Research. "CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to UCSF Radiopharmaceutical Facility, 2026-04-13." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ucsf-radiopharmaceutical-facility-2026-04-13-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ucsf_radiopharmaceutical_facility_2026_04_13_cgmp_2026,
title = {CGMP/Finished Pharmaceuticals/Adulterated: FDA Warning Letter to UCSF Radiopharmaceutical Facility, 2026-04-13},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ucsf-radiopharmaceutical-facility-2026-04-13-cgmp},
note = {Accessed: July 13, 2026}
}