YANGZHOU DANDISI FAMILY CARE PRO
✅ Low Risk
FEI: 3012823903 • Yangzhoucity • CHINA
FEI Number
3012823903
Location
Yangzhoucity
Country
CHINAAddress
# 6 Tongzhou Rd, Hangji, Guangling District, Yangzhoucity, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
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).
Refusal History
Frequently Asked Questions
What is YANGZHOU DANDISI FAMILY CARE PRO's FDA import refusal history?
YANGZHOU DANDISI FAMILY CARE PRO (FEI: 3012823903) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2016 to 10/18/2016.
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. YANGZHOU DANDISI FAMILY CARE PRO's FEI number is 3012823903.
What types of violations has YANGZHOU DANDISI FAMILY CARE PRO received?
YANGZHOU DANDISI FAMILY CARE PRO 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 YANGZHOU DANDISI FAMILY CARE PRO come from?
All FDA import refusal data for YANGZHOU DANDISI FAMILY CARE PRO 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.