Beijing Wantai Biological Pharmacy Enterprise Co Ltd
⚠️ Moderate Risk
FEI: 3005825861 • Beijing, Beijing • CHINA
FEI Number
3005825861
Location
Beijing, Beijing
Country
CHINAAddress
31 Kexueyuan Road, Changping, Beijing, Beijing, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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 |
|---|---|---|---|
| 7/20/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | Division of Southeast Imports (DSEI) | |
| 10/18/2018 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 10/18/2018 | 82MZFTEST, HIV DETECTION | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 10/18/2018 | 81MTPANTIBODY TO HTLV-1, ELISA | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 10/18/2018 | 83LQIHEPATITIS DELTA SEROLOGICAL REAGENTS | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 3/30/2017 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | Division of Southeast Imports (DSEI) | |
| 8/24/2011 | 75JJCANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 11/17/2005 | 83LIQENZYME LINKED IMMUNOABSORBENT ASSAY, ROTAVIRUS | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 82MZFTEST, HIV DETECTION | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 82LOKKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 81MTPANTIBODY TO HTLV-1, ELISA | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 82MZFTEST, HIV DETECTION | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 83MZOASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS | San Francisco District Office (SAN-DO) | |
| 11/17/2005 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | San Francisco District Office (SAN-DO) | |
| 2/5/2004 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Beijing Wantai Biological Pharmacy Enterprise Co Ltd's FDA import refusal history?
Beijing Wantai Biological Pharmacy Enterprise Co Ltd (FEI: 3005825861) has 15 FDA import refusal record(s) in our database, spanning from 2/5/2004 to 7/20/2020.
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. Beijing Wantai Biological Pharmacy Enterprise Co Ltd's FEI number is 3005825861.
What types of violations has Beijing Wantai Biological Pharmacy Enterprise Co Ltd received?
Beijing Wantai Biological Pharmacy Enterprise 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 Beijing Wantai Biological Pharmacy Enterprise Co Ltd come from?
All FDA import refusal data for Beijing Wantai Biological Pharmacy Enterprise 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.