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Changsha Gree Biotechnology Co.Ltd.

⚠️ Moderate Risk

FEI: 3010134714 • Chagnsha • CHINA

FEI

FEI Number

3010134714

📍

Location

Chagnsha

🇨🇳

Country

CHINA
🏢

Address

B4-612 Shanshui Mingyuan District,Kaiyun, , Chagnsha, , China

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/16/2013
Latest Refusal
5/16/2013
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

31001×

ANDRO

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

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
5/16/2013
46YH99FOOD ADDITIVES FOR HUMAN USE, N.E.C.
3100ANDRO
Los Angeles District Office (LOS-DO)
5/16/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Changsha Gree Biotechnology Co.Ltd.'s FDA import refusal history?

Changsha Gree Biotechnology Co.Ltd. (FEI: 3010134714) has 2 FDA import refusal record(s) in our database, spanning from 5/16/2013 to 5/16/2013.

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. Changsha Gree Biotechnology Co.Ltd.'s FEI number is 3010134714.

What types of violations has Changsha Gree Biotechnology Co.Ltd. received?

Changsha Gree Biotechnology 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 Changsha Gree Biotechnology Co.Ltd. come from?

All FDA import refusal data for Changsha Gree Biotechnology 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.