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Nanjing Baijingyu Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3010164504 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3010164504

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Nanjing Economical High-Tech, No. 1 Huizhong Lu, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/26/2008
Latest Refusal
1/30/2008
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

721×

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.

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
3/26/2008
56KAS10CHLORAMPHENICOL
72NEW VET DR
Florida District Office (FLA-DO)
1/30/2008
56KCS10CHLORAMPHENICOL
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Nanjing Baijingyu Pharmaceutical Co., Ltd.'s FDA import refusal history?

Nanjing Baijingyu Pharmaceutical Co., Ltd. (FEI: 3010164504) has 2 FDA import refusal record(s) in our database, spanning from 1/30/2008 to 3/26/2008.

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. Nanjing Baijingyu Pharmaceutical Co., Ltd.'s FEI number is 3010164504.

What types of violations has Nanjing Baijingyu Pharmaceutical Co., Ltd. received?

Nanjing Baijingyu Pharmaceutical 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 Nanjing Baijingyu Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Nanjing Baijingyu Pharmaceutical 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.