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Unique Biotech Limited

⚠️ Moderate Risk

FEI: 3003873503 • Hyderabad • INDIA

FEI

FEI Number

3003873503

📍

Location

Hyderabad

🇮🇳

Country

INDIA
🏢

Address

Plot No 123 Phase V, , Hyderabad, , India

Moderate Risk

FDA Import Risk Assessment

37.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/9/2007
Latest Refusal
6/21/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.1×10%
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.

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

DateProductViolationsDivision
10/9/2007
41YHY99DIETARY CONVENTIONAL FOODS, N.E.C.
238UNSAFE ADD
New Orleans District Office (NOL-DO)
6/21/2004
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Unique Biotech Limited's FDA import refusal history?

Unique Biotech Limited (FEI: 3003873503) has 2 FDA import refusal record(s) in our database, spanning from 6/21/2004 to 10/9/2007.

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. Unique Biotech Limited's FEI number is 3003873503.

What types of violations has Unique Biotech Limited received?

Unique Biotech Limited 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 Unique Biotech Limited come from?

All FDA import refusal data for Unique Biotech Limited 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.