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Hetero Drugs Limited

⚠️ Moderate Risk

FEI: 3009225386 • Anakapalli, Andhra Pradesh • INDIA

FEI

FEI Number

3009225386

📍

Location

Anakapalli, Andhra Pradesh

🇮🇳

Country

INDIA
🏢

Address

(Unit IX), Plot 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapally Mandal, Anakapalli, Andhra Pradesh, India

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/3/2019
Latest Refusal
5/3/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
5/3/2019
66MCR99TRANQUILIZER N.E.C.
16DIRECTIONS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Hetero Drugs Limited's FDA import refusal history?

Hetero Drugs Limited (FEI: 3009225386) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2019 to 5/3/2019.

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. Hetero Drugs Limited's FEI number is 3009225386.

What types of violations has Hetero Drugs Limited received?

Hetero Drugs Limited 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 Hetero Drugs Limited come from?

All FDA import refusal data for Hetero Drugs Limited 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.