Shaanxi Creation Medical Appliances Co., Ltd.
⚠️ Moderate Risk
FEI: 3004072824 • Xian, Shanxi • CHINA
FEI Number
3004072824
Location
Xian, Shanxi
Country
CHINAAddress
Bldg. 3 F/4, No. 1 C., Xian, Shanxi, 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
Frequently Asked Questions
What is Shaanxi Creation Medical Appliances Co., Ltd.'s FDA import refusal history?
Shaanxi Creation Medical Appliances Co., Ltd. (FEI: 3004072824) has 2 FDA import refusal record(s) in our database, spanning from 8/29/2006 to 8/29/2006.
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. Shaanxi Creation Medical Appliances Co., Ltd.'s FEI number is 3004072824.
What types of violations has Shaanxi Creation Medical Appliances Co., Ltd. received?
Shaanxi Creation Medical Appliances 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 Shaanxi Creation Medical Appliances Co., Ltd. come from?
All FDA import refusal data for Shaanxi Creation Medical Appliances 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.