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Taizhou Taifa Pharmaceuticals Co., Ltd.

⚠️ Moderate Risk

FEI: 3003849542 • Taizhou, Zhejiang • CHINA

FEI

FEI Number

3003849542

📍

Location

Taizhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No.14, Industrial East Road, , Xianju, Taizhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

32.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
1/12/2017
Latest Refusal
3/11/2003
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.4×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

751×

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
1/12/2017
65JIY21MEDROXYPROGESTERONE ACETATE (PROGESTIN)
16DIRECTIONS
2880RXCOMPOUND
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/11/2003
65JAS21MEDROXYPROGESTERONE ACETATE (PROGESTIN)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Taizhou Taifa Pharmaceuticals Co., Ltd.'s FDA import refusal history?

Taizhou Taifa Pharmaceuticals Co., Ltd. (FEI: 3003849542) has 2 FDA import refusal record(s) in our database, spanning from 3/11/2003 to 1/12/2017.

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. Taizhou Taifa Pharmaceuticals Co., Ltd.'s FEI number is 3003849542.

What types of violations has Taizhou Taifa Pharmaceuticals Co., Ltd. received?

Taizhou Taifa Pharmaceuticals Co., Ltd. has been cited for 3 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 Taizhou Taifa Pharmaceuticals Co., Ltd. come from?

All FDA import refusal data for Taizhou Taifa Pharmaceuticals 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.