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Sd Sawheny

⚠️ Moderate Risk

FEI: 3008596148 • Jammu • INDIA

FEI

FEI Number

3008596148

📍

Location

Jammu

🇮🇳

Country

INDIA
🏢

Address

291 Krshna Magard Canal Road, , Jammu, , India

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
1/6/2011
Latest Refusal
1/6/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

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
1/6/2011
61SBA99ANTI-ECZEMATIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2011
62NBF99ANTI-PSORIATIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2011
63HDR99CATHARTIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2011
60LCA99ANALGESIC, N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2011
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sd Sawheny's FDA import refusal history?

Sd Sawheny (FEI: 3008596148) has 5 FDA import refusal record(s) in our database, spanning from 1/6/2011 to 1/6/2011.

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. Sd Sawheny's FEI number is 3008596148.

What types of violations has Sd Sawheny received?

Sd Sawheny 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 Sd Sawheny come from?

All FDA import refusal data for Sd Sawheny 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.