FDA Inspection
Du-Var LaboratoryDu-Var Laboratory – FDA Inspection, Oct 20, 2023
Record Details
This FDA Inspection record concerns Du-Var Laboratory, with an inspection on October 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9174dd03-e190-4b9d-881e-62c267530cf0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220916
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Du-Var Laboratory
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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