Company
United StatesEchopixel, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Echopixel, Inc. in Santa Clara, California. 2 FDA inspections on record, 1 Form 483, last inspected January 15, 2025.
Company Profile
This profile covers Echopixel, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 2, 2022. Last inspected January 15, 2025.
Most cited issue areas
- Complaints1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1258966 |
| December 2, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1191841 |
FDA documents
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Company Information
Name
Echopixel, Inc.
FEI Number
3011501361
Address
4677 Old Ironsides Dr Ste 445, Santa Clara, California 95054, United States
Country
United States
ID: fa2eed1b-8dbd-4aeb-8dae-527b89587c30