JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD.
⚠️ Moderate Risk
FEI: 3012086357 • Zhangjiagang, Jiangsu • CHINA
FEI Number
3012086357
Location
Zhangjiagang, Jiangsu
Country
CHINAAddress
No.29,North Guotai Road,Ecomomic&Technological Development, South Side Of Dongqi Road, Zhangjiagang, Jiangsu, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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.
Refusal History
Frequently Asked Questions
What is JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD.'s FDA import refusal history?
JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD. (FEI: 3012086357) has 2 FDA import refusal record(s) in our database, spanning from 8/14/2018 to 12/20/2024.
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. JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD.'s FEI number is 3012086357.
What types of violations has JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD. received?
JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD. has been cited for 5 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 JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD. come from?
All FDA import refusal data for JIANGSU BAIDE MEDICAL INSTRUMENT 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.