China Shenyang Meheco I/E. Co., LTD
⚠️ Moderate Risk
FEI: 3008779043 • Shenyang, Liaoning • CHINA
FEI Number
3008779043
Location
Shenyang, Liaoning
Country
CHINAAddress
Int'L Trade Bldg., 35 Youth St; Shenhe District, Shenyang, Liaoning, 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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/18/2004 | 54YCL04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 7/27/2004 | 95U28MERCURY VAPOR LAMP FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 11/4/2003 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 290DE IMP GMP | Chicago District Office (CHI-DO) |
| 3/18/2003 | 80FLKTHERMOMETER, CLINICAL MERCURY | 126FAILS STD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is China Shenyang Meheco I/E. Co., LTD's FDA import refusal history?
China Shenyang Meheco I/E. Co., LTD (FEI: 3008779043) has 5 FDA import refusal record(s) in our database, spanning from 3/18/2003 to 4/28/2005.
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. China Shenyang Meheco I/E. Co., LTD's FEI number is 3008779043.
What types of violations has China Shenyang Meheco I/E. Co., LTD received?
China Shenyang Meheco I/E. Co., LTD has been cited for 7 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 China Shenyang Meheco I/E. Co., LTD come from?
All FDA import refusal data for China Shenyang Meheco I/E. 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.