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Sami Labs Limited (Hyderabad Unit)

⚠️ Moderate Risk

FEI: 3006530396 • Rangareddy, Andhra Pradesh • INDIA

FEI

FEI Number

3006530396

📍

Location

Rangareddy, Andhra Pradesh

🇮🇳

Country

INDIA
🏢

Address

Plot 12A. S.P. Biotech Park, Genome Valley, Rangareddy, Andhra Pradesh, India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/5/2013
Latest Refusal
7/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

37211×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

Refusal History

DateProductViolationsDivision
7/5/2013
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3721PESTICIDE2
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sami Labs Limited (Hyderabad Unit)'s FDA import refusal history?

Sami Labs Limited (Hyderabad Unit) (FEI: 3006530396) has 1 FDA import refusal record(s) in our database, spanning from 7/5/2013 to 7/5/2013.

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. Sami Labs Limited (Hyderabad Unit)'s FEI number is 3006530396.

What types of violations has Sami Labs Limited (Hyderabad Unit) received?

Sami Labs Limited (Hyderabad Unit) 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 Sami Labs Limited (Hyderabad Unit) come from?

All FDA import refusal data for Sami Labs Limited (Hyderabad Unit) 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.