TAIWAN BIOTECH CO., LTD.
⚠️ High Risk
FEI: 3003598505 • Taoyuan City, Taoyuan • TAIWAN
FEI Number
3003598505
Location
Taoyuan City, Taoyuan
Country
TAIWANAddress
Taoyuan District, 22 Chieh-Shou Rd., Taoyuan City, Taoyuan, 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
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).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/10/2024 | 61KIK05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/10/2024 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/6/2013 | 65FBK06WATER, PURIFIED (EYEWASH) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/20/2010 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/30/2010 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2010 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 223FALSE | Los Angeles District Office (LOS-DO) |
| 10/22/2008 | 65VDB53ESTAZOLAM (SEDATIVE) | San Francisco District Office (SAN-DO) | |
| 10/22/2008 | 61NDB29FLUOXETINE (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 12/12/2006 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/29/2004 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/29/2004 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/7/2004 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is TAIWAN BIOTECH CO., LTD.'s FDA import refusal history?
TAIWAN BIOTECH CO., LTD. (FEI: 3003598505) has 12 FDA import refusal record(s) in our database, spanning from 4/7/2004 to 9/10/2024.
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. TAIWAN BIOTECH CO., LTD.'s FEI number is 3003598505.
What types of violations has TAIWAN BIOTECH CO., LTD. received?
TAIWAN 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 TAIWAN BIOTECH CO., LTD. come from?
All FDA import refusal data for TAIWAN 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.