FDA Inspection
Scope Medical Devices Private LimitedScope Medical Devices Private Limited – FDA Inspection, Aug 6, 2026
Record Details
This FDA Inspection record concerns Scope Medical Devices Private Limited, with an inspection on August 6, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 6, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 76b2e735-ff63-4b83-b533-1e2829520f98
Inspection Facts
- Inspection number
- 1330466
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of Scope Medical Devices Private Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Scope Medical Devices Private Limited
- FDA Inspection 808631 - 2012-11-08
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