FDA Inspection
Oxalis LabsOxalis Labs – FDA Inspection, Jun 2, 2023
Record Details
This FDA Inspection record concerns Oxalis Labs, with an inspection on June 2, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8bb46ad9-3dd7-419a-9bc8-90abb2823b54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207969
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
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Other FDA inspections of Oxalis Labs
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| March 14, 2025 | Not classified | Office of Inspections and Investigations | |
| August 2, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| January 20, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 19, 2016 | Not classified | Office of Inspections and Investigations |
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