Xian Lyphar Biotech Co Ltd
⚠️ Moderate Risk
FEI: 3010636702 • Xian • CHINA
FEI Number
3010636702
Location
Xian
Country
CHINAAddress
Tang NO 11, Yan Rd Hi Tech; Ind Zone, Xian, , 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
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.
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.
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).
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.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2023 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 10/22/2019 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/25/2019 | 54FBR49GUARANA (HERBAL & BOTANICALS, NOT TEAS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 2/15/2019 | 66VAS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/8/2019 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 8/18/2017 | 54ABA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Division of Southeast Imports (DSEI) | |
| 9/1/2016 | 62CCP41MINOXIDIL (ANTI-HYPERTENSIVE) | Seattle District Office (SEA-DO) | |
| 4/15/2016 | 89MOZACID, HYALURONIC, INTRAARTICULAR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Xian Lyphar Biotech Co Ltd's FDA import refusal history?
Xian Lyphar Biotech Co Ltd (FEI: 3010636702) has 8 FDA import refusal record(s) in our database, spanning from 4/15/2016 to 5/26/2023.
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. Xian Lyphar Biotech Co Ltd's FEI number is 3010636702.
What types of violations has Xian Lyphar Biotech Co Ltd received?
Xian Lyphar Biotech Co Ltd has been cited for 10 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 Xian Lyphar Biotech Co Ltd come from?
All FDA import refusal data for Xian Lyphar Biotech 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.