Taiyen Biotech Co., Ltd.
⚠️ Moderate Risk
FEI: 3004611628 • Tainan • TAIWAN
FEI Number
3004611628
Location
Tainan
Country
TAIWANAddress
No. 297 Chen-Kang Road, Sec. 1, , Tainan, , Taiwan
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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 10/12/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Seattle District Office (SEA-DO) | |
| 10/12/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 5/24/2012 | 66PBU99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/24/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/24/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/25/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/14/2004 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Taiyen Biotech Co., Ltd.'s FDA import refusal history?
Taiyen Biotech Co., Ltd. (FEI: 3004611628) has 8 FDA import refusal record(s) in our database, spanning from 9/14/2004 to 5/9/2013.
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. Taiyen Biotech Co., Ltd.'s FEI number is 3004611628.
What types of violations has Taiyen Biotech Co., Ltd. received?
Taiyen Biotech Co., Ltd. has been cited for 4 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 Taiyen Biotech Co., Ltd. come from?
All FDA import refusal data for Taiyen 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.