Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
⚠️ High Risk
FEI: 3004117486 • Ezhou, Hubei • CHINA
FEI Number
3004117486
Location
Ezhou, Hubei
Country
CHINAAddress
No. 25 Juxian Road; Gedian Development Zone, , Ezhou, Hubei, 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.
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).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2024 | 65JCT31PROGESTERONE (PROGESTIN) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/23/2024 | 65JCT31PROGESTERONE (PROGESTIN) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/7/2024 | 65JCT31PROGESTERONE (PROGESTIN) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 6/12/2017 | 65JCY31PROGESTERONE (PROGESTIN) | Division of West Coast Imports (DWCI) | |
| 5/16/2017 | 65JCC31PROGESTERONE (PROGESTIN) | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 3/28/2016 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/30/2015 | 64UCS06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 4/24/2015 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/22/2015 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hubei Gedian Humanwell Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (FEI: 3004117486) has 9 FDA import refusal record(s) in our database, spanning from 4/22/2015 to 10/24/2024.
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. Hubei Gedian Humanwell Pharmaceutical Co., Ltd.'s FEI number is 3004117486.
What types of violations has Hubei Gedian Humanwell Pharmaceutical Co., Ltd. received?
Hubei Gedian Humanwell 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 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hubei Gedian Humanwell 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.