Company
United StatesElekta, Inc., Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Elekta, Inc. in Sunnyvale, California. 3 FDA inspections on record, last inspected August 26, 2015.
Company Profile
This profile covers Elekta, Inc. based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 28, 2009. Last inspected August 26, 2015.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 26, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 940239 |
| November 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 753194 |
| September 28, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 616125 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elekta, Inc.
FEI Number
1000123805
Address
100 Mathilda Pl, 5th Floor, Sunnyvale, California 94086, United States
Country
United States
ID: 4dd144dc-7caa-42d9-bb35-f4f60970a67e