FDA Inspection
Oxalis LabsOxalis Labs – FDA Inspection, Jan 20, 2017
Record Details
This FDA Inspection record concerns Oxalis Labs, with an inspection on January 20, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 1f6d813b-b604-4f81-ac3a-455096a80408
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004227
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
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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 | |
| June 2, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| October 19, 2016 | Not classified | Office of Inspections and Investigations |
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