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Sheetal Ayuverda

⚠️ Moderate Risk

FEI: 3005980375 • Vile Parle • INDIA

FEI

FEI Number

3005980375

📍

Location

Vile Parle

🇮🇳

Country

INDIA
🏢

Address

Shop No2 Harmyadam Ram Mandir Road, , Vile Parle, , India

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
12/6/2006
Latest Refusal
12/6/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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
12/6/2006
62UDA99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/6/2006
62UBA99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/6/2006
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New York District Office (NYK-DO)
12/6/2006
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sheetal Ayuverda's FDA import refusal history?

Sheetal Ayuverda (FEI: 3005980375) has 4 FDA import refusal record(s) in our database, spanning from 12/6/2006 to 12/6/2006.

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. Sheetal Ayuverda's FEI number is 3005980375.

What types of violations has Sheetal Ayuverda received?

Sheetal Ayuverda 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 Sheetal Ayuverda come from?

All FDA import refusal data for Sheetal Ayuverda 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.