GUANGDONG CMIC IMP AND EXP CO LT
⚠️ Moderate Risk
FEI: 3015712362 • Guangzhou, Guangdong • CHINA
FEI Number
3015712362
Location
Guangzhou, Guangdong
Country
CHINAAddress
Hao 172 Xian Street, , Guangzhou, Guangdong, 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).
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 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).
Refusal History
Frequently Asked Questions
What is GUANGDONG CMIC IMP AND EXP CO LT's FDA import refusal history?
GUANGDONG CMIC IMP AND EXP CO LT (FEI: 3015712362) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2019 to 10/21/2019.
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. GUANGDONG CMIC IMP AND EXP CO LT's FEI number is 3015712362.
What types of violations has GUANGDONG CMIC IMP AND EXP CO LT received?
GUANGDONG CMIC IMP AND EXP CO LT has been cited for 3 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 GUANGDONG CMIC IMP AND EXP CO LT come from?
All FDA import refusal data for GUANGDONG CMIC IMP AND EXP CO LT 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.