Company
IndiaScope Medical Devices Private Limited, Ambala, India – FDA Inspections
Inspection records and compliance data for Scope Medical Devices Private Limited in Ambala. 2 FDA inspections on record, 1 Form 483, last inspected August 06, 2026.
Company Profile
This profile covers Scope Medical Devices Private Limited based in Ambala, India.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 8, 2012. Last inspected August 6, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Records of risk management activities in product realization not maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 6, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1330466 |
| November 8, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 808631 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Scope Medical Devices Private Limited
FEI Number
3006455037
Address
11/10 Survey Number, Jaraut Road; Village Mandhour, Ambala, India
Country
India
ID: 3a23887d-b6dd-443a-8a8d-ba768a689e39