Amsar Private Ltd
⚠️ Moderate Risk
FEI: 1000133185 • Indore, Madhya Pradesh • INDIA
FEI Number
1000133185
Location
Indore, Madhya Pradesh
Country
INDIAAddress
47, , Indore, Madhya Pradesh, 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).
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/21/2007 | 28NET99RAW MATERIAL FOR EXTRACTS AND FLAVORS, N.E.C. | 3120EPHEDALK | New Orleans District Office (NOL-DO) |
| 8/17/2005 | 62GAR99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 12/21/2004 | 60NAR99ANDROGEN, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Amsar Private Ltd's FDA import refusal history?
Amsar Private Ltd (FEI: 1000133185) has 3 FDA import refusal record(s) in our database, spanning from 12/21/2004 to 6/21/2007.
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. Amsar Private Ltd's FEI number is 1000133185.
What types of violations has Amsar Private Ltd received?
Amsar Private 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 Amsar Private Ltd come from?
All FDA import refusal data for Amsar 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.