M/S Eminence Research & Developm
⚠️ Moderate Risk
FEI: 3012319837 • Chandigarh • INDIA
FEI Number
3012319837
Location
Chandigarh
Country
INDIAAddress
Scf-393 1st Floor Motor Market M, , Chandigarh, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/30/2016 | 60NDP14TESTOSTERONE (ANDROGEN) | New Orleans District Office (NOL-DO) | |
| 6/30/2016 | 60KCP99ANABOLIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/30/2016 | 60NCP19TESTOSTERONE PROPIONATE (ANDROGEN) | New Orleans District Office (NOL-DO) | |
| 6/30/2016 | 60KCP08METHENOLONE ENANTHATE (ANABOLIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is M/S Eminence Research & Developm's FDA import refusal history?
M/S Eminence Research & Developm (FEI: 3012319837) has 4 FDA import refusal record(s) in our database, spanning from 6/30/2016 to 6/30/2016.
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. M/S Eminence Research & Developm's FEI number is 3012319837.
What types of violations has M/S Eminence Research & Developm received?
M/S Eminence Research & Developm has been cited for 2 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 M/S Eminence Research & Developm come from?
All FDA import refusal data for M/S Eminence Research & Developm 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.