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Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical

⚠️ Moderate Risk

FEI: 3003675881 • Zhaoqing, Guangdong • CHINA

FEI

FEI Number

3003675881

📍

Location

Zhaoqing, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Dinghu District, Lianhua Road; Kengkou Town, Zhaoqing, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/7/2002
Latest Refusal
12/21/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

162×

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
3/7/2002
62VCS12RIBAVIRIN (ANTI-VIRAL)
16DIRECTIONS
San Juan District Office (SJN-DO)
12/21/2001
62VCS12RIBAVIRIN (ANTI-VIRAL)
16DIRECTIONS
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical's FDA import refusal history?

Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical (FEI: 3003675881) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2001 to 3/7/2002.

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. Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical's FEI number is 3003675881.

What types of violations has Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical received?

Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical 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 Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical come from?

All FDA import refusal data for Star Lake Bioscience Co. Inc. Zhaoqing Guangdong Star Lake Biochemical 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.