Company
United StatesAvalign Delivery Systems Division, Greenwood, IN – FDA Inspections
Inspection records and compliance data for Avalign Delivery Systems Division in Greenwood, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected May 23, 2018.
Company Profile
This profile covers Avalign Delivery Systems Division based in Greenwood, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected April 30, 2009. Last inspected May 23, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1053732 |
| August 5, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 889789 |
| August 9, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 793541 |
| April 30, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 580993 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Avalign Delivery Systems Division
FEI Number
3000717687
Address
2121 Southtech Dr Ste 600, Greenwood, Indiana 46143, United States
Country
United States
ID: 654c7764-0843-46a9-b9cc-6f27d6a8606c