FDA Inspection
University of CaliforniaUniversity of California – FDA Inspection, Jan 15, 2013
Record Details
This FDA Inspection record concerns University of California, with an inspection on January 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- University of California
- Inspection Date
- January 15, 2013
- Product Type
- Drugs
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ID · 3228711a-852e-4154-b7fd-6f962a6ab54d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814193
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of University of California
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for University of California
- FDA Inspection 899940 - 2014-10-09
- FDA Inspection 760142 - 2011-12-16
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