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Alembic Pharmaceuticals Ltd.

⚠️ Moderate Risk

FEI: 3007501748 • Padra, Gujarat • INDIA

FEI

FEI Number

3007501748

📍

Location

Padra, Gujarat

🇮🇳

Country

INDIA
🏢

Address

Survey No 842 - 843, , Padra, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

48.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/7/2023
Latest Refusal
4/26/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
26.6×20%
Frequency
2.8×10%
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

753×

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
2/7/2023
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2021
62HCA03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/26/2012
56ICB76AZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Alembic Pharmaceuticals Ltd.'s FDA import refusal history?

Alembic Pharmaceuticals Ltd. (FEI: 3007501748) has 3 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 2/7/2023.

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. Alembic Pharmaceuticals Ltd.'s FEI number is 3007501748.

What types of violations has Alembic Pharmaceuticals Ltd. received?

Alembic Pharmaceuticals 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 Alembic Pharmaceuticals Ltd. come from?

All FDA import refusal data for Alembic Pharmaceuticals 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.