ANHUI INTCO MEDICAL PRODUCTS CO., LTD.
⚠️ High Risk
FEI: 3017610877 • Huaibei, Anhui • CHINA
FEI Number
3017610877
Location
Huaibei, Anhui
Country
CHINAAddress
No.6 Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County,, No.6, Shuangchuang Avenue, Suixi EconomicDevelopment Zone, Huaibei, Anhui, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2024 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Northern Border Imports (DNBI) | |
| 1/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 12/12/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/12/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/12/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/29/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/17/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/3/2023 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 10/24/2023 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 10/13/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ANHUI INTCO MEDICAL PRODUCTS CO., LTD.'s FDA import refusal history?
ANHUI INTCO MEDICAL PRODUCTS CO., LTD. (FEI: 3017610877) has 10 FDA import refusal record(s) in our database, spanning from 10/13/2023 to 2/27/2024.
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. ANHUI INTCO MEDICAL PRODUCTS CO., LTD.'s FEI number is 3017610877.
What types of violations has ANHUI INTCO MEDICAL PRODUCTS CO., LTD. received?
ANHUI INTCO MEDICAL PRODUCTS CO., LTD. has been cited for 3 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 ANHUI INTCO MEDICAL PRODUCTS CO., LTD. come from?
All FDA import refusal data for ANHUI INTCO 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.