FDA Inspection
QuVa Pharma, Inc.QuVa Pharma, Inc. – FDA Inspection, Oct 28, 2024
Record Details
This FDA Inspection record concerns QuVa Pharma, Inc., with an inspection on October 28, 2024, issued by the Dallas District Office, covering human drugs.
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ID · cc614ef7-bea2-4730-8607-e4f953a946fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238474
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| August 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 23, 2019 | OAI | 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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