Company
United StatesAuxigen Pharmaceutical, LLC, Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Auxigen Pharmaceutical, LLC in Indianapolis, Indiana. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected July 08, 2014.
Company Profile
This profile covers Auxigen Pharmaceutical, LLC based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected June 14, 2011. Last inspected July 8, 2014.
Most cited issue areas
- Cleaning/maintenance records not kept1 inspection
- Complaint Investigation/Follow-Up Findings1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 8, 2014 | OAI | Human Drugs · Drug Quality Assurance | 887645 |
| June 14, 2011 | VAI | Human Drugs · Drug Quality Assurance | 729979 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Auxigen Pharmaceutical, LLC
FEI Number
3004971302
Address
3250 N Post Rd Ste 279, Indianapolis, Indiana 46226, United States
Country
United States
ID: 55625c8d-119d-4e07-a947-52f60d8a6a7c