Fuzhou Difeng Bio-Tech Co., Ltd.
⚠️ Moderate Risk
FEI: 3007648407 • Fuzhou, Fujian • CHINA
FEI Number
3007648407
Location
Fuzhou, Fujian
Country
CHINAAddress
Jinshan Industrial, 6 Yangqi Sub Road; Cangshan, Fuzhou, Fujian, 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).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2016 | 76EGGATTACHMENT, PRECISION, ALL | Los Angeles District Office (LOS-DO) | |
| 1/8/2013 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | Chicago District Office (CHI-DO) | |
| 6/6/2011 | 53IK01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 6/6/2011 | 53IK01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 6/6/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/6/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/6/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/6/2011 | 53PF99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/24/2010 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 7/1/2010 | 53IC99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/22/2009 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | 341REGISTERED | Chicago District Office (CHI-DO) |
| 8/27/2008 | 53IK99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/30/2008 | 62FBL47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Fuzhou Difeng Bio-Tech Co., Ltd.'s FDA import refusal history?
Fuzhou Difeng Bio-Tech Co., Ltd. (FEI: 3007648407) has 13 FDA import refusal record(s) in our database, spanning from 4/30/2008 to 9/29/2016.
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. Fuzhou Difeng Bio-Tech Co., Ltd.'s FEI number is 3007648407.
What types of violations has Fuzhou Difeng Bio-Tech Co., Ltd. received?
Fuzhou Difeng Bio-Tech Co., Ltd. has been cited for 11 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 Fuzhou Difeng Bio-Tech Co., Ltd. come from?
All FDA import refusal data for Fuzhou Difeng Bio-Tech 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.