Taiyen Biotech Co Ltd

⚠️ Moderate Risk

FEI: 3005220957 • Budai Township • TAIWAN

FEI

FEI Number

3005220957

📍

Location

Budai Township

🇹🇼

Country

TAIWAN

🏢

Address

No 1 Liou Dong Liao, , Budai Township, , Taiwan

Moderate Risk

FDA Import Risk Assessment

37.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/2/2011

Latest Refusal

6/2/2011

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

47110×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

47310×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

Date	Product	Violations	Division
6/2/2011	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)
6/2/2011	53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Taiyen Biotech Co Ltd's FDA import refusal history?

Taiyen Biotech Co Ltd (FEI: 3005220957) has 10 FDA import refusal record(s) in our database, spanning from 6/2/2011 to 6/2/2011.

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 3005220957.

What types of violations has Taiyen Biotech Co Ltd received?

Taiyen Biotech Co Ltd has been cited for 2 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.