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Torque Pharmaceuticals (P) Ltd.

⚠️ Moderate Risk

FEI: 3004860027 • Issapur • INDIA

FEI

FEI Number

3004860027

📍

Location

Issapur

🇮🇳

Country

INDIA
🏢

Address

P.O. Dappar 140-506, , Issapur, , India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/28/2018
Latest Refusal
2/28/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

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
2/28/2018
61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
178COL ADDED
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Torque Pharmaceuticals (P) Ltd.'s FDA import refusal history?

Torque Pharmaceuticals (P) Ltd. (FEI: 3004860027) has 1 FDA import refusal record(s) in our database, spanning from 2/28/2018 to 2/28/2018.

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. Torque Pharmaceuticals (P) Ltd.'s FEI number is 3004860027.

What types of violations has Torque Pharmaceuticals (P) Ltd. received?

Torque Pharmaceuticals (P) Ltd. has been cited for 2 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 Torque Pharmaceuticals (P) Ltd. come from?

All FDA import refusal data for Torque Pharmaceuticals (P) 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.