Amar Remedies Ltd.
⚠️ Moderate Risk
FEI: 2000024870 • Daman, Daman and Diu • INDIA
FEI Number
2000024870
Location
Daman, Daman and Diu
Country
INDIAAddress
375/14 Hill Industrial Estate, Zari Road, Kachigam, Daman, Daman and Diu, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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
Frequently Asked Questions
What is Amar Remedies Ltd.'s FDA import refusal history?
Amar Remedies Ltd. (FEI: 2000024870) has 1 FDA import refusal record(s) in our database, spanning from 1/19/2012 to 1/19/2012.
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. Amar Remedies Ltd.'s FEI number is 2000024870.
What types of violations has Amar Remedies Ltd. received?
Amar Remedies Ltd. 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 Amar Remedies Ltd. come from?
All FDA import refusal data for Amar Remedies 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.