FDA Inspection
Mayo Clinic PET Radiochemistry FacilityMayo Clinic PET Radiochemistry Facility – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns Mayo Clinic PET Radiochemistry Facility, with an inspection on May 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 9322dba4-00a3-417b-a5cc-d18ee7e14a29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011376
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.30(b)Equipment not clean
- 21 CFR 212.40(c)Designation of incoming lots
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.60(b)Testing Procedures- Conformance to Standards
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mayo Clinic PET Radiochemistry Facility
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
| December 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mayo Clinic PET Radiochemistry Facility
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.