Sinochem Ningbo Latex Gloves
⚠️ Moderate Risk
FEI: 3002813861 • Ningbo • CHINA
FEI Number
3002813861
Location
Ningbo
Country
CHINAAddress
Hua Lian Bldg. Floor 11-12, 21 Jiangxia Street, Ningbo, , 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.
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 |
|---|---|---|---|
| 10/26/2006 | 66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/26/2006 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/11/2002 | 80FRLFIBER, MEDICAL, ABSORBENT | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/11/2002 | 80FRLFIBER, MEDICAL, ABSORBENT | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/11/2002 | 80FRLFIBER, MEDICAL, ABSORBENT | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/11/2002 | 80FRLFIBER, MEDICAL, ABSORBENT | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sinochem Ningbo Latex Gloves's FDA import refusal history?
Sinochem Ningbo Latex Gloves (FEI: 3002813861) has 6 FDA import refusal record(s) in our database, spanning from 4/11/2002 to 10/26/2006.
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. Sinochem Ningbo Latex Gloves's FEI number is 3002813861.
What types of violations has Sinochem Ningbo Latex Gloves received?
Sinochem Ningbo Latex Gloves 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 Sinochem Ningbo Latex Gloves come from?
All FDA import refusal data for Sinochem Ningbo Latex Gloves 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.