FDA Inspection
California Pharmaceuticals LLCCalifornia Pharmaceuticals LLC – FDA Inspection, Dec 12, 2018
Record Details
This FDA Inspection record concerns California Pharmaceuticals LLC, with an inspection on December 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bda4d9d8-5dc2-4e21-8d48-9b70fb51e599
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074455
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 310.305(a)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of California Pharmaceuticals LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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 1045497 - 2018-03-23
- 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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