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SKM SIDDHA AND AYURVEDHA COMPANY

⚠️ High Risk

FEI: 3016973605 • Erode • INDIA

FEI

FEI Number

3016973605

📍

Location

Erode

🇮🇳

Country

INDIA
🏢

Address

Saminathapuram Modakkur, , Erode, , India

High Risk

FDA Import Risk Assessment

54.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/20/2025
Latest Refusal
12/6/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
73.9×20%
Frequency
8.5×10%
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

753×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
6/20/2025
56YDA99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/27/2024
65CDB99NUTRIENT/TONIC N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/6/2021
62UDZ99ANTI-TUSSIVE/COLD N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SKM SIDDHA AND AYURVEDHA COMPANY's FDA import refusal history?

SKM SIDDHA AND AYURVEDHA COMPANY (FEI: 3016973605) has 3 FDA import refusal record(s) in our database, spanning from 12/6/2021 to 6/20/2025.

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. SKM SIDDHA AND AYURVEDHA COMPANY's FEI number is 3016973605.

What types of violations has SKM SIDDHA AND AYURVEDHA COMPANY received?

SKM SIDDHA AND AYURVEDHA COMPANY 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 SKM SIDDHA AND AYURVEDHA COMPANY come from?

All FDA import refusal data for SKM SIDDHA AND AYURVEDHA COMPANY 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.