FDA Inspection
Davion IncDavion Inc – FDA Inspection, May 10, 2012
Record Details
This FDA Inspection record concerns Davion Inc, with an inspection on May 10, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Davion Inc
- Inspection Date
- May 10, 2012
- Product Type
- Drugs
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ID · a35d59aa-11d9-4785-bb79-40d96af94c46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778949
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.182Dedicated equipment: records part of batch record
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Davion Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| May 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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