FDA Inspection
ONESOURCE SPECIALTY PHARMA LIMITEDONESOURCE SPECIALTY PHARMA LIMITED – FDA Inspection, Sep 1, 2022
Record Details
This FDA Inspection record concerns ONESOURCE SPECIALTY PHARMA LIMITED, with an inspection on September 1, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 1, 2022
- Product Type
- Devices
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ID · 83dbd5fb-7073-4d16-80b9-a2ee5e877048
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179406
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of ONESOURCE SPECIALTY PHARMA LIMITED
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
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