FDA Inspection
Oxalis LabsOxalis Labs – FDA Inspection, Aug 2, 2019
Record Details
This FDA Inspection record concerns Oxalis Labs, with an inspection on August 2, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · f9ab2459-8778-4a50-b125-cb8a4bfec5d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098333
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192No written record of investigation
- 21 CFR 211.25(c)Inadequate number of personnel
Full citation text and observation details available on the Dashboard.
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 |
| January 20, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 19, 2016 | Not classified | Office of Inspections and Investigations |
Other documents for Oxalis Labs
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.