Baoying County Fukang Medical Appliance Co., Ltd.
⚠️ Moderate Risk
FEI: 3006795842 • Yangzhou, Jiangsu • CHINA
FEI Number
3006795842
Location
Yangzhou, Jiangsu
Country
CHINAAddress
Guangyang Road, Huangcheng Town Industry Area, Baoying, Yangzhou, Jiangsu, 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).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
Frequently Asked Questions
What is Baoying County Fukang Medical Appliance Co., Ltd.'s FDA import refusal history?
Baoying County Fukang Medical Appliance Co., Ltd. (FEI: 3006795842) has 1 FDA import refusal record(s) in our database, spanning from 7/17/2023 to 7/17/2023.
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. Baoying County Fukang Medical Appliance Co., Ltd.'s FEI number is 3006795842.
What types of violations has Baoying County Fukang Medical Appliance Co., Ltd. received?
Baoying County Fukang Medical Appliance 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 Baoying County Fukang Medical Appliance Co., Ltd. come from?
All FDA import refusal data for Baoying County Fukang Medical Appliance 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.