FDA Inspection
Davion IncDavion Inc – FDA Inspection, Jan 22, 2014
Record Details
This FDA Inspection record concerns Davion Inc, with an inspection on January 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Davion Inc
- Inspection Date
- January 22, 2014
- Product Type
- Drugs
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ID · 7e3cca8d-8f41-4781-b96c-3c1f79c2a25d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862373
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.103Yield calculations not verified by 2nd person
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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 |
| May 10, 2012 | 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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