Company
United StatesAssertio Therapeutics, Inc., Lake Forest, IL – FDA Inspections
Inspection records and compliance data for Assertio Therapeutics, Inc. in Lake Forest, Illinois. 6 FDA inspections on record, 1 Form 483, last inspected September 04, 2025.
Company Profile
This profile covers Assertio Therapeutics, Inc. based in Lake Forest, Illinois, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 25, 2010. Last inspected September 4, 2025.
Most cited issue areas
- Procedures not in writing, fully followed1 inspection
- Records reviewed annually1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2025 | Not classified | Human Drugs | 1281169 |
| November 9, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1192639 |
| February 22, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1163048 |
| March 26, 2021 | NAI | Human Drugs · Bioresearch Monitoring | 1141337 |
| November 2, 2016 | VAI | Human Drugs · Drug Quality Assurance | 991565 |
| May 25, 2010 | VAI | Human Drugs · Drug Quality Assurance | 662609 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Assertio Therapeutics, Inc.
FEI Number
3003099171
Address
100 Saunders Rd Ste 300, Lake Forest, Illinois 60045, United States
Country
United States
ID: b3e30900-d46d-47b0-996f-f4217eecbcd2