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Huxley & Co. (India)

⚠️ Moderate Risk

FEI: 3009066715 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3009066715

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

18 Shamaldas Gandhi Marg, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/7/2011
Latest Refusal
10/7/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/7/2011
66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Huxley & Co. (India)'s FDA import refusal history?

Huxley & Co. (India) (FEI: 3009066715) has 1 FDA import refusal record(s) in our database, spanning from 10/7/2011 to 10/7/2011.

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. Huxley & Co. (India)'s FEI number is 3009066715.

What types of violations has Huxley & Co. (India) received?

Huxley & Co. (India) 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 Huxley & Co. (India) come from?

All FDA import refusal data for Huxley & Co. (India) 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.