Sms Pharmaceuticals Ltd
⚠️ Moderate Risk
FEI: 3007637830 • Hyderabad • INDIA
FEI Number
3007637830
Location
Hyderabad
Country
INDIAAddress
No 19 3rd Floor Manikanta Towers Uti, , Hyderabad, , 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2014 | 61TCY27ONDANSETRON HCL DIHYDRATE (ANTI-EMETIC/NAUSEANT) | 3280FRNMFGREG | New Orleans District Office (NOL-DO) |
| 9/22/2014 | 60SAY22FAMOTIDINE (ANTACID) | New Orleans District Office (NOL-DO) | |
| 10/20/2010 | 65PCZ02SILDENAFIL CITRATE (REGULATOR) | New York District Office (NYK-DO) | |
| 10/20/2010 | 65PIR02SILDENAFIL CITRATE (REGULATOR) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sms Pharmaceuticals Ltd's FDA import refusal history?
Sms Pharmaceuticals Ltd (FEI: 3007637830) has 4 FDA import refusal record(s) in our database, spanning from 10/20/2010 to 10/16/2014.
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. Sms Pharmaceuticals Ltd's FEI number is 3007637830.
What types of violations has Sms Pharmaceuticals Ltd received?
Sms Pharmaceuticals Ltd has been cited for 3 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 Sms Pharmaceuticals Ltd come from?
All FDA import refusal data for Sms Pharmaceuticals 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.