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FDA Inspection
•Mayo Clinic PET Radiochemistry Facility•April 12, 2019

Mayo Clinic PET Radiochemistry Facility – FDA Inspection, Apr 12, 2019

Record Details

This FDA Inspection record concerns Mayo Clinic PET Radiochemistry Facility, with an inspection on April 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mayo Clinic PET Radiochemistry Facility
Inspection Date
April 12, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Libia M. Lugo (Issuing Officer)
View Company Profile

ID · f00232dc-67eb-46b5-b1d2-6d9ed7883a7b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1086402
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
  2. 21 CFR 212.30(b)Equipment procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mayo Clinic PET Radiochemistry Facility

1
DateClassificationOfficeProject area
July 17, 2026Not classifiedFlorida District OfficeDrug Quality Assurance
Other documents for Mayo Clinic PET Radiochemistry Facility
  • FDA Inspection 1326754 - 2026-07-17

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