Company
IrelandAOTI Ltd., Galway, Ireland – FDA Inspections
Inspection records and compliance data for AOTI Ltd. in Galway. 2 FDA inspections on record, last inspected July 20, 2017.
Company Profile
This profile covers AOTI Ltd. based in Galway, Ireland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 22, 2010. Last inspected July 20, 2017.
Most cited issue areas
- Design history file1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1038662 |
| April 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 661652 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AOTI Ltd.
FEI Number
3006538358
Address
Sycamore House, Parkmore Business Park West, Galway, Ireland
Country
Ireland
ID: 2cf338d4-560c-4ebe-a4a5-1eb10d1c5e57