KYJ Medical Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3008840181 • Changzhou, Jiangsu • CHINA
FEI Number
3008840181
Location
Changzhou, Jiangsu
Country
CHINAAddress
Huadu Village Industrial Zone, Lijia Town, Wujin, Changzhou, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2015 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/2/2014 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 5/2/2014 | 62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is KYJ Medical Products Co., Ltd.'s FDA import refusal history?
KYJ Medical Products Co., Ltd. (FEI: 3008840181) has 3 FDA import refusal record(s) in our database, spanning from 5/2/2014 to 1/13/2015.
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. KYJ Medical Products Co., Ltd.'s FEI number is 3008840181.
What types of violations has KYJ Medical Products Co., Ltd. received?
KYJ Medical Products 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 KYJ Medical Products Co., Ltd. come from?
All FDA import refusal data for KYJ Medical Products 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.