FDA Inspection
University of Southern California, DBA USC Molecular Imaging CenterUniversity of Southern California, DBA USC Molecular Imaging Center – FDA Inspection, Aug 14, 2019
Record Details
This FDA Inspection record concerns University of Southern California, DBA USC Molecular Imaging Center, with an inspection on August 14, 2019, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- August 14, 2019
- Product Type
- Human Drugs
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ID · 4ef404d2-0a68-45b2-8e52-b79edd0e7c7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099550
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.60(c)Analytical methods
- 21 CFR 212.60(f)Lab written procedures
- 21 CFR 212.60(g)(3)Complete record of all laboratory test data
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Other FDA inspections of University of Southern California, DBA USC Molecular Imaging Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2018 | Not classified | Los Angeles District Office | |
| December 2, 2016 | VAI | Los Angeles District Office | Generic Drug Evaluation |
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