FDA Inspection
University Of PA Department of Radiology Cyclotron FacilityUniversity Of PA Department of Radiology Cyclotron Facility – FDA Inspection, Jun 30, 2016
Record Details
This FDA Inspection record concerns University Of PA Department of Radiology Cyclotron Facility, with an inspection on June 30, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 30, 2016
- Product Type
- Drugs
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ID · c295752b-fc89-412d-83fb-96c642509d0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983668
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(b)Examine, approve or reject
- 21 CFR 212.20(c)Adverse effects of changes made
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(b)Equipment not suitable
- 21 CFR 212.10Lack Adequate Resources, Facilities, Equipment.
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Other FDA inspections of University Of PA Department of Radiology Cyclotron Facility
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for University Of PA Department of Radiology Cyclotron Facility
- FDA Inspection 1288270 - 2025-09-10
- FDA Inspection 868812 - 2014-03-04
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