Qilu Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003674637 • Jinan, Shandong • CHINA
FEI Number
3003674637
Location
Jinan, Shandong
Country
CHINAAddress
No. 23999 Gongyebei North Rd, Licheng District, Jinan, Shandong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/3/2010 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2010 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2010 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Qilu Pharmaceutical Co., Ltd.'s FDA import refusal history?
Qilu Pharmaceutical Co., Ltd. (FEI: 3003674637) has 3 FDA import refusal record(s) in our database, spanning from 8/3/2010 to 8/3/2010.
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 Co., Ltd.'s FEI number is 3003674637.
What types of violations has Qilu Pharmaceutical Co., Ltd. received?
Qilu Pharmaceutical 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 Qilu Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Qilu 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.