Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004060039 • Zhangjiang, Guangdong • CHINA
FEI Number
3004060039
Location
Zhangjiang, Guangdong
Country
CHINAAddress
NO. 59 Renmin South Road, , Zhangjiang, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
Frequently Asked Questions
What is Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.'s FDA import refusal history?
Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. (FEI: 3004060039) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2015 to 12/18/2015.
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. Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.'s FEI number is 3004060039.
What types of violations has Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. received?
Guangdong Zhanjiang Jimin Pharmaceutical 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 Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Guangdong Zhanjiang Jimin Pharmaceutical 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.