Company
United StatesMarlex Pharmaceuticals, Inc., New Castle, DE – FDA Inspections
Inspection records and compliance data for Marlex Pharmaceuticals, Inc. in New Castle, Delaware. 8 FDA inspections on record, 1 Form 483, last inspected November 14, 2025.
Company Profile
This profile covers Marlex Pharmaceuticals, Inc. based in New Castle, Delaware, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected March 22, 2010. Last inspected November 14, 2025.
Most cited issue areas
- Storage under appropriate conditions2 inspections
- Adequate lighting not provided1 inspection
- Air filtration system lacking in production area1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 14, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1291594 |
| April 14, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1169769 |
| August 12, 2021 | VAI | Human Drugs · Bioresearch Monitoring | 1148584 |
| September 6, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1028879 |
| June 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 931349 |
| August 24, 2011 | NAI | Human Drugs · Drug Quality Assurance | 741052 |
| October 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 682729 |
| March 22, 2010 | VAI | Human Drugs · Drug Quality Assurance | 652686 |
FDA documents
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Company Information
Name
Marlex Pharmaceuticals, Inc.
FEI Number
1000121454
Address
65 Lukens Dr, New Castle, Delaware 19720, United States
Country
United States
ID: 0da60eaf-e48c-4cfe-9df6-f7136f19b0f5