ImportRefusal LogoImportRefusal

Nanjing Pharmaceutical Factory Co., Ltd.

⚠️ Moderate Risk

FEI: 3004674350 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3004674350

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

9 Fang Shuilu, Liuhe, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/30/2012
Latest Refusal
8/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

272×

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).

Refusal History

DateProductViolationsDivision
5/30/2012
55RY99PHARMACEUTIC NECESSITIES, N.E.C.
27DRUG GMPS
New Orleans District Office (NOL-DO)
8/23/2011
55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
27DRUG GMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Nanjing Pharmaceutical Factory Co., Ltd. (FEI: 3004674350) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 5/30/2012.

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 Pharmaceutical Factory Co., Ltd.'s FEI number is 3004674350.

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

Nanjing Pharmaceutical Factory Co., Ltd. has been cited for 1 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 Pharmaceutical Factory Co., Ltd. come from?

All FDA import refusal data for Nanjing Pharmaceutical Factory 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.