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983668

Cyclotron Facility University of Pennsylvania — FEI 3006333738

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1288270 (NAI Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868812 (NAI Tue Mar 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1772221 CFR 212.10Lack Adequate Resources, Facilities, Equipment.
1774221 CFR 212.30(b)Equipment not suitable
1775721 CFR 212.20(b)Examine, approve or reject
1775921 CFR 212.20(c)Adverse effects of changes made
1776321 CFR 212.20(d)Determination need for investigation
1776421 CFR 212.20(e)Written QA procedures established, followed