Company
United StatesElekta, Inc., Atlanta, GA – FDA Inspections
Inspection records and compliance data for Elekta, Inc. in Atlanta, Georgia. 2 FDA inspections on record, last inspected December 13, 2019.
Company Profile
This profile covers Elekta, Inc. based in Atlanta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 21, 2010. Last inspected December 13, 2019.
Most cited issue areas
- Management review - defined interval, sufficient frequency1 inspection
- Report of Death or Serious Injury1 inspection
- Time to report - 10 days1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 13, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1123129 |
| May 21, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 665439 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Elekta, Inc.
FEI Number
1037831
Address
400 Perimeter Center Ter NE Ste 50, Atlanta, Georgia 30346, United States
Country
United States
ID: 19c772ce-d4b9-4cb7-bfa3-5f2fac4e2ba8