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Qilu Pharmaceutical (Hainan) Co. Ltd.

⚠️ Moderate Risk

FEI: 3008250362 • Haikou, Hainan • CHINA

FEI

FEI Number

3008250362

📍

Location

Haikou, Hainan

🇨🇳

Country

CHINA
🏢

Address

No. 273-A Nanhai Avenue, Changliuzhen Xiuying District, Haikou, Hainan, China

Moderate Risk

FDA Import Risk Assessment

39.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/3/2023
Latest Refusal
10/3/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
54.0×20%
Frequency
10.0×10%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
10/3/2023
62VDE01AMANTADINE HCL (ANTI-VIRAL)
472NO ENGLISH
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Qilu Pharmaceutical (Hainan) Co. Ltd.'s FDA import refusal history?

Qilu Pharmaceutical (Hainan) Co. Ltd. (FEI: 3008250362) has 1 FDA import refusal record(s) in our database, spanning from 10/3/2023 to 10/3/2023.

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. Qilu Pharmaceutical (Hainan) Co. Ltd.'s FEI number is 3008250362.

What types of violations has Qilu Pharmaceutical (Hainan) Co. Ltd. received?

Qilu Pharmaceutical (Hainan) 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 Qilu Pharmaceutical (Hainan) Co. Ltd. come from?

All FDA import refusal data for Qilu Pharmaceutical (Hainan) 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.