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Dr. Jrk Shiddha Research And Pharma

⚠️ Moderate Risk

FEI: 3007728477 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3007728477

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

19 Pedariyar Koil Street, , Chennai, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/30/2009
Latest Refusal
9/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
9/30/2009
61WBO99A-FUNGAL N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
9/30/2009
61WBK99A-FUNGAL N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dr. Jrk Shiddha Research And Pharma's FDA import refusal history?

Dr. Jrk Shiddha Research And Pharma (FEI: 3007728477) has 2 FDA import refusal record(s) in our database, spanning from 9/30/2009 to 9/30/2009.

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. Dr. Jrk Shiddha Research And Pharma's FEI number is 3007728477.

What types of violations has Dr. Jrk Shiddha Research And Pharma received?

Dr. Jrk Shiddha Research And Pharma 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 Dr. Jrk Shiddha Research And Pharma come from?

All FDA import refusal data for Dr. Jrk Shiddha Research And Pharma 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.