FDA Inspection
Canyon Formulations LLCCanyon Formulations LLC – FDA Inspection, Nov 16, 2011
Record Details
This FDA Inspection record concerns Canyon Formulations LLC, with an inspection on November 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Canyon Formulations LLC
- Inspection Date
- November 16, 2011
- Product Type
- Drugs
View Company Profile
ID · f6aab964-7508-462b-a50a-0f68683b6f65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752331
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.42(c)Defined areas of adequate size for operations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Canyon Formulations LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Canyon Formulations LLC
- FDA Inspection 1095053 - 2019-05-17
- FDA Inspection 960323 - 2016-01-26
- FDA Inspection 838748 - 2013-06-20
- FDA Inspection 710548 - 2011-01-31
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