FDA Inspection
Canyon Formulations LLCCanyon Formulations LLC – FDA Inspection, Jan 26, 2016
Record Details
This FDA Inspection record concerns Canyon Formulations LLC, with an inspection on January 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Canyon Formulations LLC
- Inspection Date
- January 26, 2016
- Product Type
- Drugs
View Company Profile
ID · 84ccb743-d7c6-43dd-a926-9747c5a16d52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960323
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.180(e)(1)Review of representative number of batches
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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 |
| June 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2011 | 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 838748 - 2013-06-20
- FDA Inspection 752331 - 2011-11-16
- FDA Inspection 710548 - 2011-01-31
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