Mayinglong Pharmaceutical Group Co., Ltd.
⚠️ Moderate Risk
FEI: 3004363818 • Wuhan, Hubei • CHINA
FEI Number
3004363818
Location
Wuhan, Hubei
Country
CHINAAddress
100 Zhoujiawan, Nanhu, Hongshan District, , Wuhan, Hubei, 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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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 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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2019 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | Division of Northeast Imports (DNEI) | |
| 8/24/2016 | 65LBJ06CALAMINE (PROTECTANT) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 11/3/2015 | 55QY18YELLOW OINTMENT (PHARMACEUTIC NECESSITY - OINTMENT BASE) | Los Angeles District Office (LOS-DO) | |
| 11/3/2015 | 55QY18YELLOW OINTMENT (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 11/3/2015 | 55QY18YELLOW OINTMENT (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 7/5/2013 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 6/20/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/7/2013 | 65LBM06CALAMINE (PROTECTANT) | Division of Northeast Imports (DNEI) | |
| 2/2/2009 | 55QG19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mayinglong Pharmaceutical Group Co., Ltd.'s FDA import refusal history?
Mayinglong Pharmaceutical Group Co., Ltd. (FEI: 3004363818) has 9 FDA import refusal record(s) in our database, spanning from 2/2/2009 to 10/9/2019.
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. Mayinglong Pharmaceutical Group Co., Ltd.'s FEI number is 3004363818.
What types of violations has Mayinglong Pharmaceutical Group Co., Ltd. received?
Mayinglong Pharmaceutical Group 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 Mayinglong Pharmaceutical Group Co., Ltd. come from?
All FDA import refusal data for Mayinglong Pharmaceutical Group 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.