Nantong City Eastwood Biotechnology
⚠️ Moderate Risk
FEI: 3010304380 • Nantongnantong • CHINA
FEI Number
3010304380
Location
Nantongnantong
Country
CHINAAddress
Star Lake Road 1692 Block A No., , Nantongnantong, , 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.
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2013 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Cincinnati District Office (CIN-DO) | |
| 11/22/2013 | 75CEPRADIOIMMUNOASSAY, LUTEINIZING HORMONE | Cincinnati District Office (CIN-DO) | |
| 11/22/2013 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Nantong City Eastwood Biotechnology's FDA import refusal history?
Nantong City Eastwood Biotechnology (FEI: 3010304380) has 3 FDA import refusal record(s) in our database, spanning from 11/22/2013 to 11/29/2013.
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. Nantong City Eastwood Biotechnology's FEI number is 3010304380.
What types of violations has Nantong City Eastwood Biotechnology received?
Nantong City Eastwood Biotechnology 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 Nantong City Eastwood Biotechnology come from?
All FDA import refusal data for Nantong City Eastwood Biotechnology 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.