Guangdong Hengjian Pharmaceutical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3009517624 • Jiangmen, Guangdong • CHINA
FEI Number
3009517624
Location
Jiangmen, Guangdong
Country
CHINAAddress
No. 117 Longxi Road, Waihaizhen Jianghai, Jiangmen, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(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).
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2023 | 56ICJ10ERYTHROMYCIN (MACROLIDES) | Division of Northeast Imports (DNEI) | |
| 4/1/2021 | 56ICJ10ERYTHROMYCIN (MACROLIDES) | Division of Northeast Imports (DNEI) | |
| 3/7/2013 | 56ICO10ERYTHROMYCIN (MACROLIDES) | Division of Northeast Imports (DNEI) | |
| 3/7/2013 | 56ECJ80TETRACYCLINE (TETRACYCLINES) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Guangdong Hengjian Pharmaceutical Co.,Ltd.'s FDA import refusal history?
Guangdong Hengjian Pharmaceutical Co.,Ltd. (FEI: 3009517624) has 4 FDA import refusal record(s) in our database, spanning from 3/7/2013 to 10/3/2023.
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 Hengjian Pharmaceutical Co.,Ltd.'s FEI number is 3009517624.
What types of violations has Guangdong Hengjian Pharmaceutical Co.,Ltd. received?
Guangdong Hengjian Pharmaceutical Co.,Ltd. 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 Guangdong Hengjian Pharmaceutical Co.,Ltd. come from?
All FDA import refusal data for Guangdong Hengjian Pharmaceutical 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.