FDA Inspection
QuVa Pharma, Inc.QuVa Pharma, Inc. – FDA Inspection, Jan 23, 2015
Record Details
This FDA Inspection record concerns QuVa Pharma, Inc., with an inspection on January 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- QuVa Pharma, Inc.
- Inspection Date
- January 23, 2015
- Product Type
- Drugs
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ID · 7090edc4-1561-4fd6-8e38-0c314501993d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912138
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| December 8, 2016 | 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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