Company
United StatesElekta Inc, Saint Charles, MO – FDA Inspections
Inspection records and compliance data for Elekta Inc in Saint Charles, Missouri. 5 FDA inspections on record, 1 Form 483, last inspected September 16, 2022.
Company Profile
This profile covers Elekta Inc based in Saint Charles, Missouri, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 14, 2010. Last inspected September 16, 2022.
Most cited issue areas
- Analyzing service report1 inspection
- Design output - review and approval1 inspection
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1190646 |
| February 10, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003704 |
| December 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 955076 |
| June 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 730299 |
| May 14, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 665312 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elekta Inc
FEI Number
1937649
Address
1450 Beale St Apt 205, Saint Charles, Missouri 63303, United States
Country
United States
ID: 220c0a14-2bf9-4e56-9705-ccb709bd9a70