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FDA Inspection
•Mayo Clinic PET Radiochemistry Facility•September 24, 2025

Mayo Clinic PET Radiochemistry Facility – FDA Inspection, Sep 24, 2025

Record Details

This FDA Inspection record concerns Mayo Clinic PET Radiochemistry Facility, with an inspection on September 24, 2025, issued by the Minneapolis District Office, covering human drugs.

Company
Mayo Clinic PET Radiochemistry Facility
Inspection Date
September 24, 2025
Product Type
Human Drugs
Office
Minneapolis District Office
Person
  • Andrew Le (FDA Associated Person)
View Company Profile

ID · c91c66f9-8ab5-4221-a1ea-da5c7e4d5377

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1283146
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 212.50Adequate controls (general)

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mayo Clinic PET Radiochemistry Facility

4
DateClassificationOfficeProject area
December 4, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 3, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 11, 2014VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
March 15, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mayo Clinic PET Radiochemistry Facility
  • FDA Inspection 950152 - 2015-12-04
  • FDA Inspection 937220 - 2015-08-03
  • FDA Inspection 886802 - 2014-07-11
  • FDA Inspection 771806 - 2012-03-15

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