ZHENDE MEDICAL CO., LTD.
⚠️ Moderate Risk
FEI: 3003348807 • Shaoxing, Zhejiang • CHINA
FEI Number
3003348807
Location
Shaoxing, Zhejiang
Country
CHINAAddress
Gaobu Town, , Shaoxing, Zhejiang, 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2018 | 80DWLSTOCKING, MEDICAL SUPPORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/19/2018 | 79NACDRESSING, WOUND, HYDROPHILIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/26/2017 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 6/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 8/14/2015 | 79MHWDRESSING, COMPRESSION | New York District Office (NYK-DO) | |
| 7/20/2015 | 79MHWDRESSING, COMPRESSION | New York District Office (NYK-DO) | |
| 3/25/2015 | 79MHWDRESSING, COMPRESSION | 479DV QUALITY | Cincinnati District Office (CIN-DO) |
| 2/17/2015 | 79MHWDRESSING, COMPRESSION | 78STERILITY | New York District Office (NYK-DO) |
| 12/30/2014 | 79MHWDRESSING, COMPRESSION | 78STERILITY | New York District Office (NYK-DO) |
| 2/28/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 2800POSS N/STR | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 2/24/2012 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 78STERILITY | New York District Office (NYK-DO) |
| 9/21/2010 | 79KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ZHENDE MEDICAL CO., LTD.'s FDA import refusal history?
ZHENDE MEDICAL CO., LTD. (FEI: 3003348807) has 26 FDA import refusal record(s) in our database, spanning from 9/21/2010 to 7/19/2018.
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. ZHENDE MEDICAL CO., LTD.'s FEI number is 3003348807.
What types of violations has ZHENDE MEDICAL CO., LTD. received?
ZHENDE MEDICAL CO., LTD. has been cited for 6 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 ZHENDE MEDICAL CO., LTD. come from?
All FDA import refusal data for ZHENDE MEDICAL 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.