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Hiranis Pharmaceuticals (Pvt.) Ltd.

⚠️ Moderate Risk

FEI: 3015924459 • Karachi, Sindh • PAKISTAN

FEI

FEI Number

3015924459

📍

Location

Karachi, Sindh

🇵🇰

Country

PAKISTAN
🏢

Address

D-41, Block 4 Clifton Karachi Pakistan, , Karachi, Sindh, Pakistan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/23/2020
Latest Refusal
4/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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
4/23/2020
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Hiranis Pharmaceuticals (Pvt.) Ltd.'s FDA import refusal history?

Hiranis Pharmaceuticals (Pvt.) Ltd. (FEI: 3015924459) has 1 FDA import refusal record(s) in our database, spanning from 4/23/2020 to 4/23/2020.

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. Hiranis Pharmaceuticals (Pvt.) Ltd.'s FEI number is 3015924459.

What types of violations has Hiranis Pharmaceuticals (Pvt.) Ltd. received?

Hiranis Pharmaceuticals (Pvt.) Ltd. 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 Hiranis Pharmaceuticals (Pvt.) Ltd. come from?

All FDA import refusal data for Hiranis Pharmaceuticals (Pvt.) Ltd. 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.