Zhejiang Ludao Technology Co., Ltd.
⚠️ High Risk
FEI: 3006460758 • Taizhou • CHINA
FEI Number
3006460758
Location
Taizhou
Country
CHINAAddress
No. 5 Industry Road, Hairun Street, Sanmen Country, Taizhou, , 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
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2023 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 4/9/2020 | 53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2019 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 3/15/2019 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/8/2019 | 53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3847FDF4APIGMP | Division of Northeast Imports (DNEI) |
| 1/19/2018 | 61WAQ99A-FUNGAL N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 1/19/2018 | 61WAQ99A-FUNGAL N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 9/14/2017 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 115DR QUALITY | Division of West Coast Imports (DWCI) |
| 9/13/2017 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 115DR QUALITY | Division of West Coast Imports (DWCI) |
| 4/5/2017 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 5/15/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zhejiang Ludao Technology Co., Ltd.'s FDA import refusal history?
Zhejiang Ludao Technology Co., Ltd. (FEI: 3006460758) has 11 FDA import refusal record(s) in our database, spanning from 5/15/2015 to 1/4/2023.
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. Zhejiang Ludao Technology Co., Ltd.'s FEI number is 3006460758.
What types of violations has Zhejiang Ludao Technology Co., Ltd. received?
Zhejiang Ludao Technology 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 Zhejiang Ludao Technology Co., Ltd. come from?
All FDA import refusal data for Zhejiang Ludao 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.