ImportRefusal LogoImportRefusal

Zhejiang Excel Pharmaceutical Company, Ltd.

⚠️ Moderate Risk

FEI: 3005280475 • Taizhou, Zhejiang • CHINA

FEI

FEI Number

3005280475

📍

Location

Taizhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Huangyan, 9 Dazha Road; Economic Development Zone, Taizhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/29/2013
Latest Refusal
4/15/2013
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

© 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.

722×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
7/29/2013
62YCT07MELOXICAM (ANTI-INFLAMMATORY, PART II)
16DIRECTIONS
72NEW VET DR
Seattle District Office (SEA-DO)
4/15/2013
62YQR07MELOXICAM (ANTI-INFLAMMATORY, PART II)
16DIRECTIONS
72NEW VET DR
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Zhejiang Excel Pharmaceutical Company, Ltd.'s FDA import refusal history?

Zhejiang Excel Pharmaceutical Company, Ltd. (FEI: 3005280475) has 2 FDA import refusal record(s) in our database, spanning from 4/15/2013 to 7/29/2013.

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. Zhejiang Excel Pharmaceutical Company, Ltd.'s FEI number is 3005280475.

What types of violations has Zhejiang Excel Pharmaceutical Company, Ltd. received?

Zhejiang Excel Pharmaceutical Company, 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 Zhejiang Excel Pharmaceutical Company, Ltd. come from?

All FDA import refusal data for Zhejiang Excel Pharmaceutical Company, 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.