Shandong Chengwu Medical Products Factory
⚠️ Moderate Risk
FEI: 3016813970 • Heze, Shandong • CHINA
FEI Number
3016813970
Location
Heze, Shandong
Country
CHINAAddress
Southern End Of Quancheng Road, Chengwu County, , Heze, Shandong, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2022 | 80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/28/2022 | 80FMHCONTAINER, SPECIMEN | Division of Northern Border Imports (DNBI) | |
| 2/11/2022 | 83QBDMICROBIAL NUCLEIC ACID STORAGE AND STABILIZATION DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/8/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 10/4/2021 | 83QMCTRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE | Division of Southeast Imports (DSEI) | |
| 4/13/2021 | 80NNICONTAINER, SPECIMEN, NON-STERILE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/13/2021 | 83LIODEVICE, SPECIMEN COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/13/2021 | 83LIODEVICE, SPECIMEN COLLECTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2021 | 80NNICONTAINER, SPECIMEN, NON-STERILE | Division of Southeast Imports (DSEI) | |
| 2/2/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shandong Chengwu Medical Products Factory's FDA import refusal history?
Shandong Chengwu Medical Products Factory (FEI: 3016813970) has 10 FDA import refusal record(s) in our database, spanning from 2/2/2021 to 5/17/2022.
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. Shandong Chengwu Medical Products Factory's FEI number is 3016813970.
What types of violations has Shandong Chengwu Medical Products Factory received?
Shandong Chengwu Medical Products 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 Shandong Chengwu Medical Products Factory come from?
All FDA import refusal data for Shandong Chengwu Medical Products 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.