Bingbing Pharmaceutical (Hubei) Co., Ltd
⚠️ Moderate Risk
FEI: 3014538973 • Shiyan, Hubei • CHINA
FEI Number
3014538973
Location
Shiyan, Hubei
Country
CHINAAddress
698 Bingbing Road, Economic Development Zone, Shiyan, Hubei, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
Frequently Asked Questions
What is Bingbing Pharmaceutical (Hubei) Co., Ltd's FDA import refusal history?
Bingbing Pharmaceutical (Hubei) Co., Ltd (FEI: 3014538973) has 3 FDA import refusal record(s) in our database, spanning from 9/25/2019 to 10/21/2019.
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. Bingbing Pharmaceutical (Hubei) Co., Ltd's FEI number is 3014538973.
What types of violations has Bingbing Pharmaceutical (Hubei) Co., Ltd received?
Bingbing Pharmaceutical (Hubei) 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 Bingbing Pharmaceutical (Hubei) Co., Ltd come from?
All FDA import refusal data for Bingbing Pharmaceutical (Hubei) 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.