Company
United StatesAurora Manufacturing LLC, Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Aurora Manufacturing LLC in Indianapolis, IN. 3 FDA inspections on record, 1 Form 483, last inspected October 31, 2016.
Company Profile
This profile covers Aurora Manufacturing LLC based in Indianapolis, IN, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 10, 2009. Last inspected October 31, 2016.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 31, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 993759 |
| April 19, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 834441 |
| November 10, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 670670 |
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
Aurora Manufacturing LLC
FEI Number
3005529226
Address
6330 E 75th St Ste 300, Indianapolis, IN 46250-2708, United States
Country
United States
ID: b1364858-ecc0-4349-a668-aa897ed6b0f6