Zhenjiang Kangda Emulsion Co,Ltd
⚠️ Moderate Risk
FEI: 3002327142 • Yangzhong, Jinagsu • CHINA
FEI Number
3002327142
Location
Yangzhong, Jinagsu
Country
CHINAAddress
Huang Shan Tao, , Yangzhong, Jinagsu, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 4/3/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Southwest Import District Office (SWI-DO) | |
| 3/19/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 2/10/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 11/29/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Minneapolis District Office (MIN-DO) |
| 3/3/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
| 3/3/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
| 3/3/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
| 3/3/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Zhenjiang Kangda Emulsion Co,Ltd's FDA import refusal history?
Zhenjiang Kangda Emulsion Co,Ltd (FEI: 3002327142) has 9 FDA import refusal record(s) in our database, spanning from 3/3/2010 to 12/17/2012.
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. Zhenjiang Kangda Emulsion Co,Ltd's FEI number is 3002327142.
What types of violations has Zhenjiang Kangda Emulsion Co,Ltd received?
Zhenjiang Kangda Emulsion 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 Zhenjiang Kangda Emulsion Co,Ltd come from?
All FDA import refusal data for Zhenjiang Kangda Emulsion 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.