Yuyao Chengze Medical Supplies Factory
⚠️ Moderate Risk
FEI: 3009711635 • Ningbo, Zhejiang • CHINA
FEI Number
3009711635
Location
Ningbo, Zhejiang
Country
CHINAAddress
Fengdongcun, Yuyao, Ningbo, Zhejiang, 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
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.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 9/1/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 6/2/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Yuyao Chengze Medical Supplies Factory's FDA import refusal history?
Yuyao Chengze Medical Supplies Factory (FEI: 3009711635) has 3 FDA import refusal record(s) in our database, spanning from 6/2/2015 to 9/1/2015.
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. Yuyao Chengze Medical Supplies Factory's FEI number is 3009711635.
What types of violations has Yuyao Chengze Medical Supplies Factory received?
Yuyao Chengze Medical Supplies Factory 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 Yuyao Chengze Medical Supplies Factory come from?
All FDA import refusal data for Yuyao Chengze Medical Supplies Factory 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.