MSN Laboratories Private Ltd.
⚠️ Moderate Risk
FEI: 3005254981 • Sangareddy, Telangana • INDIA
FEI Number
3005254981
Location
Sangareddy, Telangana
Country
INDIAAddress
Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy, Telangana, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2015 | 62GCR99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/17/2015 | 62CCS99ANTI-HYPERTENSIVE N.E.C. | Florida District Office (FLA-DO) | |
| 9/23/2013 | 61XAY50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Chicago District Office (CHI-DO) | |
| 9/19/2013 | 62UAS11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is MSN Laboratories Private Ltd.'s FDA import refusal history?
MSN Laboratories Private Ltd. (FEI: 3005254981) has 4 FDA import refusal record(s) in our database, spanning from 9/19/2013 to 11/9/2015.
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. MSN Laboratories Private Ltd.'s FEI number is 3005254981.
What types of violations has MSN Laboratories Private Ltd. received?
MSN Laboratories Private Ltd. has been cited for 4 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 MSN Laboratories Private Ltd. come from?
All FDA import refusal data for MSN Laboratories Private 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.