FDA Inspection
QuVa Pharma, Inc.QuVa Pharma, Inc. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns QuVa Pharma, Inc., with an inspection on December 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Lisa R. Whitt (Issuing Officer)
- Stephen D. Brown (FDA Associated Person)
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ID · ef427725-a408-4f10-b1f3-31ad18488a99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995263
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- FDCA 503B(a)(10)Drug product label, outsourcer facility
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Other FDA inspections of QuVa Pharma, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2018 | Not classified | Dallas District Office | Drug Quality Assurance |
| January 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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