FDA Inspection
Upsher-Smith Laboratories, LLCUpsher-Smith Laboratories, LLC – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns Upsher-Smith Laboratories, LLC, with an inspection on April 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 30, 2010
- Product Type
- Drugs
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ID · 19f0f513-af4c-49ac-9ec8-86fc84d113f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661821
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Upsher-Smith Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2019 | Not classified | Denver District Office | |
| October 10, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 25, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Upsher-Smith Laboratories, LLC
- FDA Inspection 1109100 - 2019-11-07
- FDA Inspection 1080819 - 2019-01-24
- FDA Inspection 1035142 - 2017-10-10
- FDA Inspection 803005 - 2012-09-25
- FDA Inspection 742842 - 2011-08-25
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