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Advy Chemical

⚠️ Moderate Risk

FEI: 1000243584 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

1000243584

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

534 Sandhurst Road Bridge, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/21/2009
Latest Refusal
8/21/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
8/21/2009
57FY09ANTI-HUMAN SERUM (IN-VITRO DIAGNOSTIC PRODUCTS)
2280DIRSEXMPT
New York District Office (NYK-DO)

Frequently Asked Questions

What is Advy Chemical's FDA import refusal history?

Advy Chemical (FEI: 1000243584) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 8/21/2009.

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. Advy Chemical's FEI number is 1000243584.

What types of violations has Advy Chemical received?

Advy Chemical 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 Advy Chemical come from?

All FDA import refusal data for Advy Chemical 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.