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New Fine Bio-Tech Cosmetic Co. Ltd.

⚠️ High Risk

FEI: 2000037083 • Sinjhuang, TW-TPE • TAIWAN

FEI

FEI Number

2000037083

📍

Location

Sinjhuang, TW-TPE

🇹🇼

Country

TAIWAN
🏢

Address

7f-4, No. 26 Wucyuan 2nd Road, , Wu-Ku Industry, Sinjhuang, TW-TPE, Taiwan

High Risk

FDA Import Risk Assessment

60.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

56
Total Refusals
2
Unique Violations
3/8/2023
Latest Refusal
12/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
65.0×30%
Recency
43.1×20%
Frequency
45.6×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

11856×

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).

7556×

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

DateProductViolationsDivision
3/8/2023
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/8/2014
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
12/3/2010
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is New Fine Bio-Tech Cosmetic Co. Ltd.'s FDA import refusal history?

New Fine Bio-Tech Cosmetic Co. Ltd. (FEI: 2000037083) has 56 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 3/8/2023.

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. New Fine Bio-Tech Cosmetic Co. Ltd.'s FEI number is 2000037083.

What types of violations has New Fine Bio-Tech Cosmetic Co. Ltd. received?

New Fine Bio-Tech Cosmetic 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 New Fine Bio-Tech Cosmetic Co. Ltd. come from?

All FDA import refusal data for New Fine Bio-Tech Cosmetic 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.