FDA Inspection
QuVa Pharma, Inc.QuVa Pharma, Inc. – FDA Inspection, Apr 20, 2018
Record Details
This FDA Inspection record concerns QuVa Pharma, Inc., with an inspection on April 20, 2018, issued by the Dallas District Office, covering human drugs.
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ID · f652f452-0e83-4928-ad81-10d1bd5e5419
Inspection Facts
- Inspection number
- 1049888
- 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 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.42(c)(10)Aseptic Processing Area
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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 |
| December 8, 2016 | VAI | Center for Drug Evaluation and Research | 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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