Hangzhou Johncan Mushroom Bio-technology Co.,Ltd
⚠️ High Risk
FEI: 3010187347 • Hangzhou, Zhejiang • CHINA
FEI Number
3010187347
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No.892,East ChangHong Street, DeQing, Hangzhou, Zhejiang, 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
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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(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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2025 | 25PXH99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C. | 249FILTHY | Division of West Coast Imports (DWCI) |
| 4/7/2022 | 25RGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 4/7/2022 | 25RGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 10/26/2021 | 46YA99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/26/2021 | 46YA99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/26/2021 | 46YA99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/12/2021 | 46YY99FOOD ADDITIVES FOR HUMAN USE, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2019 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/14/2016 | 25RGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Hangzhou Johncan Mushroom Bio-technology Co.,Ltd's FDA import refusal history?
Hangzhou Johncan Mushroom Bio-technology Co.,Ltd (FEI: 3010187347) has 9 FDA import refusal record(s) in our database, spanning from 11/14/2016 to 6/23/2025.
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. Hangzhou Johncan Mushroom Bio-technology Co.,Ltd's FEI number is 3010187347.
What types of violations has Hangzhou Johncan Mushroom Bio-technology Co.,Ltd received?
Hangzhou Johncan Mushroom Bio-technology Co.,Ltd has been cited for 8 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 Hangzhou Johncan Mushroom Bio-technology Co.,Ltd come from?
All FDA import refusal data for Hangzhou Johncan Mushroom Bio-technology 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.