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Hangzhou Greensky Biological Tech. Co., Ltd

⚠️ Moderate Risk

FEI: 3004689094 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3004689094

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

15-7 Shui Yin Kang Ting, Shenjia Raod, , Hangzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/4/2010
Latest Refusal
10/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

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
6/4/2010
54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
488HEALTH C
Los Angeles District Office (LOS-DO)
10/30/2009
56YDS99ANTIBIOTIC N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Hangzhou Greensky Biological Tech. Co., Ltd's FDA import refusal history?

Hangzhou Greensky Biological Tech. Co., Ltd (FEI: 3004689094) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2009 to 6/4/2010.

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. Hangzhou Greensky Biological Tech. Co., Ltd's FEI number is 3004689094.

What types of violations has Hangzhou Greensky Biological Tech. Co., Ltd received?

Hangzhou Greensky Biological Tech. Co., 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 Hangzhou Greensky Biological Tech. Co., Ltd come from?

All FDA import refusal data for Hangzhou Greensky Biological Tech. Co., 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.