Company
United StatesInsource Orthopedics, LLC, Irvine, CA – FDA Inspections
Inspection records and compliance data for Insource Orthopedics, LLC in Irvine, California. 4 FDA inspections on record, last inspected August 25, 2021.
Company Profile
This profile covers Insource Orthopedics, LLC based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 25, 2009. Last inspected August 25, 2021.
Most cited issue areas
- Control/distribution procedures1 inspection
- Establish the design and development plan1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 25, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1153740 |
| August 27, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1069140 |
| March 26, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 773850 |
| August 25, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 607359 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Insource Orthopedics, LLC
FEI Number
3005032381
Address
15550 Rockfield Blvd Ste D, Irvine, California 92618, United States
Country
United States
ID: 4a7c41f5-bb47-43f6-908c-c22e8220b555