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alok pharmaceutical & Industrial Co. Pvt. Ltd.

⚠️ High Risk

FEI: 3040879189 • sahibabad • INDIA

FEI

FEI Number

3040879189

📍

Location

sahibabad

🇮🇳

Country

INDIA
🏢

Address

b-40 Industrial Area, Site-IV, , sahibabad, , India

High Risk

FDA Import Risk Assessment

59.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
10/31/2025
Latest Refusal
10/31/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
96.0×20%
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
10/31/2025
66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is alok pharmaceutical & Industrial Co. Pvt. Ltd.'s FDA import refusal history?

alok pharmaceutical & Industrial Co. Pvt. Ltd. (FEI: 3040879189) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2025 to 10/31/2025.

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. alok pharmaceutical & Industrial Co. Pvt. Ltd.'s FEI number is 3040879189.

What types of violations has alok pharmaceutical & Industrial Co. Pvt. Ltd. received?

alok pharmaceutical & Industrial Co. 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 alok pharmaceutical & Industrial Co. Pvt. Ltd. come from?

All FDA import refusal data for alok pharmaceutical & Industrial Co. 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.