FDA Inspection
California Pharmaceuticals LLCCalifornia Pharmaceuticals LLC – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns California Pharmaceuticals LLC, with an inspection on September 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 6, 2013
- Product Type
- Drugs
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ID · 3f4b0707-9a62-4553-80d5-ac5b74b9a7a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848527
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(b)Tentative expiration date
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Other FDA inspections of California Pharmaceuticals LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2018 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| March 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for California Pharmaceuticals LLC
- FDA Inspection 1074455 - 2018-12-12
- FDA Inspection 1045497 - 2018-03-23
- FDA Inspection 908656 - 2014-11-18
- FDA Inspection 752316 - 2011-10-27
- FDA Inspection 548114 - 2008-11-04
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