FDA Inspection
California Pharmaceuticals LLCCalifornia Pharmaceuticals LLC – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns California Pharmaceuticals LLC, with an inspection on March 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e08620fe-1a93-4a1b-8e2b-9afe952e496e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045497
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| November 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2013 | 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 908656 - 2014-11-18
- FDA Inspection 848527 - 2013-09-06
- FDA Inspection 752316 - 2011-10-27
- FDA Inspection 548114 - 2008-11-04
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