Matrix Laboratories Ltd
⚠️ Moderate Risk
FEI: 3004010606 • Secunderabad • INDIA
FEI Number
3004010606
Location
Secunderabad
Country
INDIAAddress
1-1-151 Alexander Rd, , Secunderabad, , India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2012 | 61ECS09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2012 | 63AIB99BONE CALCIUM REGULATOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/14/2009 | 61JDA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Matrix Laboratories Ltd's FDA import refusal history?
Matrix Laboratories Ltd (FEI: 3004010606) has 3 FDA import refusal record(s) in our database, spanning from 1/14/2009 to 8/21/2012.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Matrix Laboratories Ltd's FEI number is 3004010606.
What types of violations has Matrix Laboratories Ltd received?
Matrix Laboratories Ltd has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Matrix Laboratories Ltd come from?
All FDA import refusal data for Matrix Laboratories Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.