Kunming Dihon Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004310316 • Kunming, Yunnan • CHINA
FEI Number
3004310316
Location
Kunming, Yunnan
Country
CHINAAddress
Kunming New & High, 45 Keyilu, Kunming, Yunnan, 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2021 | 61WAJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northern Border Imports (DNBI) | |
| 10/16/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/16/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/9/2020 | 61WAY47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2017 | 56ACA20PENICILLIN V, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2015 | 61WAJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2015 | 61WAJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Cincinnati District Office (CIN-DO) | |
| 8/2/2007 | 54YCK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kunming Dihon Pharmaceutical Co., Ltd.'s FDA import refusal history?
Kunming Dihon Pharmaceutical Co., Ltd. (FEI: 3004310316) has 8 FDA import refusal record(s) in our database, spanning from 8/2/2007 to 11/12/2021.
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. Kunming Dihon Pharmaceutical Co., Ltd.'s FEI number is 3004310316.
What types of violations has Kunming Dihon Pharmaceutical Co., Ltd. received?
Kunming Dihon Pharmaceutical 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 Kunming Dihon Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Kunming Dihon 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.