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Surya Herbal Limited

⚠️ Moderate Risk

FEI: 3004751279 • Noida, Uttar Pradesh • INDIA

FEI

FEI Number

3004751279

📍

Location

Noida, Uttar Pradesh

🇮🇳

Country

INDIA
🏢

Address

C 33 U P India, , Noida, Uttar Pradesh, India

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
5
Unique Violations
11/6/2009
Latest Refusal
8/2/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.0×10%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

31201×

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.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

751×

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
11/6/2009
54FGF94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
11UNSAFE COL
473LABELING
New Orleans District Office (NOL-DO)
11/6/2009
54YBF01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
482NUTRIT LBL
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/2/2005
54FEE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3120EPHEDALK
New York District Office (NYK-DO)

Frequently Asked Questions

What is Surya Herbal Limited's FDA import refusal history?

Surya Herbal Limited (FEI: 3004751279) has 3 FDA import refusal record(s) in our database, spanning from 8/2/2005 to 11/6/2009.

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. Surya Herbal Limited's FEI number is 3004751279.

What types of violations has Surya Herbal Limited received?

Surya Herbal Limited has been cited for 5 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 Surya Herbal Limited come from?

All FDA import refusal data for Surya Herbal 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.