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Dr P D Gupta

⚠️ Moderate Risk

FEI: 3004436354 • Ambala City • INDIA

FEI

FEI Number

3004436354

📍

Location

Ambala City

🇮🇳

Country

INDIA
🏢

Address

Near Jagadhri Gate/t B Hospital, , Ambala City, , India

Moderate Risk

FDA Import Risk Assessment

47.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
3/23/2007
Latest Refusal
7/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
29.3×10%
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
3/23/2007
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New York District Office (NYK-DO)
3/23/2007
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New York District Office (NYK-DO)
3/23/2007
61FCJ54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New York District Office (NYK-DO)
7/8/2005
61EAA99ANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
7/8/2005
61EAL99ANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dr P D Gupta's FDA import refusal history?

Dr P D Gupta (FEI: 3004436354) has 5 FDA import refusal record(s) in our database, spanning from 7/8/2005 to 3/23/2007.

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 P D Gupta's FEI number is 3004436354.

What types of violations has Dr P D Gupta received?

Dr P D Gupta 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 P D Gupta come from?

All FDA import refusal data for Dr P D Gupta 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.