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FDA Inspection
•Mayo Clinic PET Radiochemistry Facility•July 11, 2014

Mayo Clinic PET Radiochemistry Facility – FDA Inspection, Jul 11, 2014

Record Details

This FDA Inspection record concerns Mayo Clinic PET Radiochemistry Facility, with an inspection on July 11, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mayo Clinic PET Radiochemistry Facility
Inspection Date
July 11, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · f590a385-688d-48ba-9990-8cfdd7506c7a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
886802
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 314.80(c)(2)Interval
  2. 21 CFR 314.80(b)Failure to develop written procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mayo Clinic PET Radiochemistry Facility

4
DateClassificationOfficeProject area
September 24, 2025VAIMinneapolis District OfficeDrug Quality Assurance
December 4, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 3, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 15, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mayo Clinic PET Radiochemistry Facility
  • FDA Inspection 1283146 - 2025-09-24
  • FDA Inspection 950152 - 2015-12-04
  • FDA Inspection 937220 - 2015-08-03
  • FDA Inspection 771806 - 2012-03-15

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