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Inventa Chemicals Ltd

⚠️ Moderate Risk

FEI: 3003385723 • Hyderabad • INDIA

FEI

FEI Number

3003385723

📍

Location

Hyderabad

🇮🇳

Country

INDIA
🏢

Address

10-91 Sowbhagyanagar, , Hyderabad, , India

Moderate Risk

FDA Import Risk Assessment

29.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/2/2007
Latest Refusal
3/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.5×10%
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

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
11/2/2007
61HDS03TRIMETHOPRIM (ANTI-BACTERIAL)
118NOT LISTED
New York District Office (NYK-DO)
10/30/2007
61HDS03TRIMETHOPRIM (ANTI-BACTERIAL)
118NOT LISTED
New York District Office (NYK-DO)
3/28/2005
61HCU03TRIMETHOPRIM (ANTI-BACTERIAL)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Inventa Chemicals Ltd's FDA import refusal history?

Inventa Chemicals Ltd (FEI: 3003385723) has 3 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 11/2/2007.

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. Inventa Chemicals Ltd's FEI number is 3003385723.

What types of violations has Inventa Chemicals Ltd received?

Inventa Chemicals 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 Inventa Chemicals Ltd come from?

All FDA import refusal data for Inventa Chemicals 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.