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ANINA INNOTHERAPEURICS PVT LTD

⚠️ Moderate Risk

FEI: 3022074335 • Thane, Maharashtra • INDIA

FEI

FEI Number

3022074335

📍

Location

Thane, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

1 Godavari Laxmiindustrial, Unit 03; Premises Pokharan Road No, Thane, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

40.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/16/2022
Latest Refusal
6/16/2022
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
11.2×30%
Recency
28.6×20%
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

38741×

708NEWDRUG

The article has been determined to be a new drug without an approved new drug application.

38801×

708FALSE

The labeling for this article is determined to be false or misleading

Refusal History

DateProductViolationsDivision
6/16/2022
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
3874708NEWDRUG
3880708FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ANINA INNOTHERAPEURICS PVT LTD's FDA import refusal history?

ANINA INNOTHERAPEURICS PVT LTD (FEI: 3022074335) has 1 FDA import refusal record(s) in our database, spanning from 6/16/2022 to 6/16/2022.

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. ANINA INNOTHERAPEURICS PVT LTD's FEI number is 3022074335.

What types of violations has ANINA INNOTHERAPEURICS PVT LTD received?

ANINA INNOTHERAPEURICS PVT 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 ANINA INNOTHERAPEURICS PVT LTD come from?

All FDA import refusal data for ANINA INNOTHERAPEURICS 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.