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Shree Jagannath

⚠️ High Risk

FEI: 3009141080 • Puri, Odisha • INDIA

FEI

FEI Number

3009141080

📍

Location

Puri, Odisha

🇮🇳

Country

INDIA
🏢

Address

Nabakalebar Road, , Puri, Odisha, India

High Risk

FDA Import Risk Assessment

58.0
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
10/17/2011
Latest Refusal
10/17/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
40.0×30%
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

7511×

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
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/17/2011
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shree Jagannath's FDA import refusal history?

Shree Jagannath (FEI: 3009141080) has 11 FDA import refusal record(s) in our database, spanning from 10/17/2011 to 10/17/2011.

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. Shree Jagannath's FEI number is 3009141080.

What types of violations has Shree Jagannath received?

Shree Jagannath 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 Shree Jagannath come from?

All FDA import refusal data for Shree Jagannath 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.