Buzhou Biology & Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3011899197 • Shandong, Liangshan County • CHINA
FEI Number
3011899197
Location
Shandong, Liangshan County
Country
CHINAAddress
#31 N Shuipo Road, , Shandong, Liangshan County, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 Buzhou Biology & Pharmaceutical Co., Ltd's FDA import refusal history?
Buzhou Biology & Pharmaceutical Co., Ltd (FEI: 3011899197) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2015 to 12/2/2015.
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. Buzhou Biology & Pharmaceutical Co., Ltd's FEI number is 3011899197.
What types of violations has Buzhou Biology & Pharmaceutical Co., Ltd received?
Buzhou Biology & Pharmaceutical Co., Ltd has been cited for 3 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 Buzhou Biology & Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Buzhou Biology & 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.