HBH BIOTECHNOLOGY LIMITED
⚠️ High Risk
FEI: 3017056269 • Yantai, Shandong • CHINA
FEI Number
3017056269
Location
Yantai, Shandong
Country
CHINAAddress
No. 97 Zhaoyuan City, Hou De Road, Jinling Town, Yantai, Shandong, 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
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.
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.
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).
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY | Division of Southeast Imports (DSEI) | |
| 11/10/2021 | 81ORGPLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING | Division of Southeast Imports (DSEI) | |
| 9/9/2020 | 76DZDTUBE, ORTHODONTIC | Division of Southeast Imports (DSEI) | |
| 8/4/2020 | 80NNICONTAINER, SPECIMEN, NON-STERILE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HBH BIOTECHNOLOGY LIMITED's FDA import refusal history?
HBH BIOTECHNOLOGY LIMITED (FEI: 3017056269) has 5 FDA import refusal record(s) in our database, spanning from 8/4/2020 to 11/20/2025.
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. HBH BIOTECHNOLOGY LIMITED's FEI number is 3017056269.
What types of violations has HBH BIOTECHNOLOGY LIMITED received?
HBH BIOTECHNOLOGY LIMITED has been cited for 7 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 HBH BIOTECHNOLOGY LIMITED come from?
All FDA import refusal data for HBH BIOTECHNOLOGY LIMITED 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.