FDA Inspection
ONESOURCE SPECIALTY PHARMA LIMITEDONESOURCE SPECIALTY PHARMA LIMITED – FDA Inspection, Mar 28, 2025
Record Details
This FDA Inspection record concerns ONESOURCE SPECIALTY PHARMA LIMITED, with an inspection on March 28, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 77bf0f7b-6b2f-482e-86d1-48120b4b4c49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265787
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of ONESOURCE SPECIALTY PHARMA LIMITED
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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