Yicheng Goto Pharmaceuticals Co., Ltd
⚠️ Moderate Risk
FEI: 3004459466 • Xiangyang, Hubei • CHINA
FEI Number
3004459466
Location
Xiangyang, Hubei
Country
CHINAAddress
Group 1 Gaokeng, Yicheng, Xiangyang, 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
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/22/2023 | 60GOY99ALCOHOL DETERRENT, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/8/2019 | 60NAY20DEHYDROEPIANDROSTERONE (ANDROGEN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/22/2016 | 64GAS99ESTROGEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/6/2015 | 64GCS99ESTROGEN N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/19/2011 | 60NCS10OXYMETHOLONE (ANDROGEN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/16/2010 | 64GCR99ESTROGEN N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/16/2010 | 65PCR02SILDENAFIL CITRATE (REGULATOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/16/2010 | 62GCR46KETOPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/28/2008 | 65JAS31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) | |
| 12/15/2004 | 60NIZ04METHYLTESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/15/2004 | 60NIZ04METHYLTESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/15/2004 | 60NIZ04METHYLTESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Yicheng Goto Pharmaceuticals Co., Ltd's FDA import refusal history?
Yicheng Goto Pharmaceuticals Co., Ltd (FEI: 3004459466) has 12 FDA import refusal record(s) in our database, spanning from 12/15/2004 to 2/22/2023.
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. Yicheng Goto Pharmaceuticals Co., Ltd's FEI number is 3004459466.
What types of violations has Yicheng Goto Pharmaceuticals Co., Ltd received?
Yicheng Goto Pharmaceuticals Co., Ltd has been cited for 4 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 Yicheng Goto Pharmaceuticals Co., Ltd come from?
All FDA import refusal data for Yicheng Goto Pharmaceuticals 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.