Company
United StatesAccugen Laboratories, Inc., Addison, IL – FDA Inspections
Inspection records and compliance data for Accugen Laboratories, Inc. in Addison, Illinois. 4 FDA inspections on record, last inspected February 13, 2024.
Company Profile
This profile covers Accugen Laboratories, Inc. based in Addison, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected December 2, 2009. Last inspected February 13, 2024.
Most cited issue areas
- Complete test data included in records1 inspection
- No written record of investigation1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1229754 |
| December 9, 2014 | NAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 906015 |
| November 8, 2012 | NAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs · Foodborne Biological Hazards | 806879 |
| December 2, 2009 | VAI | Foods & Cosmetics, Human Drugs · Foodborne Biological Hazards | 631689 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Accugen Laboratories, Inc.
FEI Number
3003286168
Address
2121 W Army Trail Rd, Addison, Illinois 60101, United States
Country
United States
ID: d5abee17-b86a-4c91-9564-5b537d1541a0