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Ajmera Herbals Limited

⚠️ High Risk

FEI: 3009185841 • Madhya Pradesh • INDIA

FEI

FEI Number

3009185841

📍

Location

Madhya Pradesh

🇮🇳

Country

INDIA
🏢

Address

276 Sector E Sanwer Road, , Madhya Pradesh, , India

High Risk

FDA Import Risk Assessment

58.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

12
Total Refusals
1
Unique Violations
1/6/2012
Latest Refusal
12/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7512×

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

DateProductViolationsDivision
1/6/2012
66VBA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/6/2012
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
61PBE99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/27/2011
66YMY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/9/2011
54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ajmera Herbals Limited's FDA import refusal history?

Ajmera Herbals Limited (FEI: 3009185841) has 12 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 1/6/2012.

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. Ajmera Herbals Limited's FEI number is 3009185841.

What types of violations has Ajmera Herbals Limited received?

Ajmera Herbals Limited has been cited for 1 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 Ajmera Herbals Limited come from?

All FDA import refusal data for Ajmera Herbals Limited 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.