Guangdong ZhiZhen Biological Medicine Co., Ltd.
⚠️ High Risk
FEI: 3015457451 • Guangzhou, Guangdong • CHINA
FEI Number
3015457451
Location
Guangzhou, Guangdong
Country
CHINAAddress
Datian First Team, Minzhu Village, No. 5 South Street; Tanbu Town Huadu District, Guangzhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 9/17/2020 | 80MSHRESPIRATOR, SURGICAL | Division of West Coast Imports (DWCI) | |
| 8/21/2020 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) | |
| 8/18/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 8/13/2020 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 80NZJRESPIRATOR, N95, HOME USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/24/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 7/24/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/20/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 7/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/14/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/7/2020 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/30/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/24/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/24/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/15/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/15/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/15/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/15/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/15/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/12/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80OUKSURGICAL MASK WITH ANTIMICROBIAL/ANTIVIRAL AGENT | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/11/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/11/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/8/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/3/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 6/1/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 5/29/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 5/28/2020 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 5/28/2020 | 73KHAMASK, SCAVENGING | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Guangdong ZhiZhen Biological Medicine Co., Ltd.'s FDA import refusal history?
Guangdong ZhiZhen Biological Medicine Co., Ltd. (FEI: 3015457451) has 57 FDA import refusal record(s) in our database, spanning from 5/28/2020 to 11/4/2020.
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. Guangdong ZhiZhen Biological Medicine Co., Ltd.'s FEI number is 3015457451.
What types of violations has Guangdong ZhiZhen Biological Medicine Co., Ltd. received?
Guangdong ZhiZhen Biological Medicine Co., Ltd. has been cited for 6 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 ZhiZhen Biological Medicine Co., Ltd. come from?
All FDA import refusal data for Guangdong ZhiZhen Biological Medicine 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.