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H DHARI SHAH PHARMACY

⚠️ Moderate Risk

FEI: 3038733993 • Ambala Cantt • INDIA

FEI

FEI Number

3038733993

📍

Location

Ambala Cantt

🇮🇳

Country

INDIA
🏢

Address

9 Industrial Area Hsiid, , Ambala Cantt, , India

Moderate Risk

FDA Import Risk Assessment

49.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/21/2026
Latest Refusal
1/21/2026
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
11.2×30%
Recency
97.9×20%
Frequency
10.0×10%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

751×

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
1/21/2026
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is H DHARI SHAH PHARMACY's FDA import refusal history?

H DHARI SHAH PHARMACY (FEI: 3038733993) has 1 FDA import refusal record(s) in our database, spanning from 1/21/2026 to 1/21/2026.

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. H DHARI SHAH PHARMACY's FEI number is 3038733993.

What types of violations has H DHARI SHAH PHARMACY received?

H DHARI SHAH PHARMACY has been cited for 3 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 H DHARI SHAH PHARMACY come from?

All FDA import refusal data for H DHARI SHAH PHARMACY 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.