FDA WARNING_LETTER - UCSF Radiopharmaceutical Facility - July 24, 2025

FDA WARNING_LETTER for UCSF Radiopharmaceutical Facility on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for UCSF Radiopharmaceutical Facility on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 314.81(b)(1)(ii)

FD&C Act 501(a)(2)(B)

21 CFR 314.81(b)(1)

21 U.S.C. 355(k)

21 CFR(b)(4)

21 U.S.C. 351(a)(2)(B)

FD&C Act 505(k)

21 U.S.C. 356C(b)

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Record Information

Company

UCSF Radiopharmaceutical Facility

Inspection Date

July 24, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 4f8e9285-0aa0-466f-abb6-c742ec1b67d1

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