Anqiu Lu'an Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004261627 • Weifang, Shandong • CHINA
FEI Number
3004261627
Location
Weifang, Shandong
Country
CHINAAddress
No. 35 Weixu North Rd, Anqiu, Weifang, Shandong, 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
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.
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.
708NOREG
It has been determined the drug 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 Anqiu Lu'an Pharmaceutical Co., Ltd.'s FDA import refusal history?
Anqiu Lu'an Pharmaceutical Co., Ltd. (FEI: 3004261627) has 2 FDA import refusal record(s) in our database, spanning from 5/9/2006 to 4/19/2016.
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. Anqiu Lu'an Pharmaceutical Co., Ltd.'s FEI number is 3004261627.
What types of violations has Anqiu Lu'an Pharmaceutical Co., Ltd. received?
Anqiu Lu'an Pharmaceutical Co., Ltd. has been cited for 4 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 Anqiu Lu'an Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Anqiu Lu'an 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.