Maxigen Biotech, Inc.
⚠️ High Risk
FEI: 3004146122 • Taoyuan City • TAIWAN
FEI Number
3004146122
Location
Taoyuan City
Country
TAIWANAddress
Guishan District, No. 88 Keji 1st Rd.; Guishan Dist., Taoyuan City, , Taiwan
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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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).
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/17/2023 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/21/2020 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 4/23/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 4/23/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 12/21/2012 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/21/2012 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/7/2012 | 53L03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 11/7/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/27/2011 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 310POISONOUS | New England District Office (NWE-DO) |
| 10/18/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/18/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/28/2007 | 87MQVFILLER, CALCIUM SULFATE PREFORMED PELLETS | Seattle District Office (SEA-DO) | |
| 6/1/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 310POISONOUS | New York District Office (NYK-DO) |
| 1/24/2005 | 84NDUFILLER, BONE VOID, BIOACTIVE (FOR CRANIOPLASTY) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Maxigen Biotech, Inc.'s FDA import refusal history?
Maxigen Biotech, Inc. (FEI: 3004146122) has 16 FDA import refusal record(s) in our database, spanning from 1/24/2005 to 3/17/2023.
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. Maxigen Biotech, Inc.'s FEI number is 3004146122.
What types of violations has Maxigen Biotech, Inc. received?
Maxigen Biotech, Inc. 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 Maxigen Biotech, Inc. come from?
All FDA import refusal data for Maxigen Biotech, Inc. 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.