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Twilight Li Taka Pharma Ltd

⚠️ Moderate Risk

FEI: 3008550517 • Pimpri, Maharashtra • INDIA

FEI

FEI Number

3008550517

📍

Location

Pimpri, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Limited B-22 A Block, , Pimpri, Maharashtra, India

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
11/30/2010
Latest Refusal
11/30/2010
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
11/30/2010
64LAA40HYDROCORTISONE SODIUM PHOSPHATE (GLUCOCORTICOID)
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Twilight Li Taka Pharma Ltd's FDA import refusal history?

Twilight Li Taka Pharma Ltd (FEI: 3008550517) has 1 FDA import refusal record(s) in our database, spanning from 11/30/2010 to 11/30/2010.

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. Twilight Li Taka Pharma Ltd's FEI number is 3008550517.

What types of violations has Twilight Li Taka Pharma Ltd received?

Twilight Li Taka Pharma 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 Twilight Li Taka Pharma Ltd come from?

All FDA import refusal data for Twilight Li Taka Pharma 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.