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Hermes Chemical Company Pvt Ltd

⚠️ Moderate Risk

FEI: 3004727001 • Hyderabad, Andhra Pradesh • INDIA

FEI

FEI Number

3004727001

📍

Location

Hyderabad, Andhra Pradesh

🇮🇳

Country

INDIA
🏢

Address

Road No 9, , Hyderabad, Andhra Pradesh, 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
2
Unique Violations
10/15/2002
Latest Refusal
10/15/2002
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

1181×

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
10/15/2002
63BBZ02ALBUTEROL SULFATE (BRONCHODILATOR)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Hermes Chemical Company Pvt Ltd's FDA import refusal history?

Hermes Chemical Company Pvt Ltd (FEI: 3004727001) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2002 to 10/15/2002.

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. Hermes Chemical Company Pvt Ltd's FEI number is 3004727001.

What types of violations has Hermes Chemical Company Pvt Ltd received?

Hermes Chemical Company 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 Hermes Chemical Company Pvt Ltd come from?

All FDA import refusal data for Hermes Chemical Company 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.