DAVEMED HEALTHCARE CO., LTD.
⚠️ Moderate Risk
FEI: 3008161330 • Jinhua, Zhejiang • CHINA
FEI Number
3008161330
Location
Jinhua, Zhejiang
Country
CHINAAddress
Zhongjing Bldg. Room 1401, 14 Fl A, 150 Guomao Street, Jinhua, 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
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).
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.
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.
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.
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 |
|---|---|---|---|
| 9/1/2020 | 79LRRKIT, FIRST AID | Division of Southeast Imports (DSEI) | |
| 8/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/20/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/24/2017 | 79LRRKIT, FIRST AID | 78STERILITY | Division of Southwest Imports (DSWI) |
| 5/24/2017 | 79LRRKIT, FIRST AID | 78STERILITY | Division of Southwest Imports (DSWI) |
| 1/21/2015 | 79OHOFIRST AID KIT WITHOUT DRUG | Los Angeles District Office (LOS-DO) | |
| 5/7/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Seattle District Office (SEA-DO) | |
| 5/7/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Seattle District Office (SEA-DO) | |
| 4/1/2014 | 79OHOFIRST AID KIT WITHOUT DRUG | Seattle District Office (SEA-DO) | |
| 9/30/2011 | 64ABY99DISINFECTANT N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is DAVEMED HEALTHCARE CO., LTD.'s FDA import refusal history?
DAVEMED HEALTHCARE CO., LTD. (FEI: 3008161330) has 10 FDA import refusal record(s) in our database, spanning from 9/30/2011 to 9/1/2020.
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. DAVEMED HEALTHCARE CO., LTD.'s FEI number is 3008161330.
What types of violations has DAVEMED HEALTHCARE CO., LTD. received?
DAVEMED HEALTHCARE 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 DAVEMED HEALTHCARE CO., LTD. come from?
All FDA import refusal data for DAVEMED HEALTHCARE 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.