FDA Inspection
QuVa Pharma, Inc.QuVa Pharma, Inc. – FDA Inspection, Apr 23, 2019
Record Details
This FDA Inspection record concerns QuVa Pharma, Inc., with an inspection on April 23, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fa2666c5-49b3-4d5a-ac17-7936e2f05fbc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1087147
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of QuVa Pharma, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| October 28, 2024 | VAI | Dallas District Office | Drug Quality Assurance |
| August 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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