Shandong Xinhua & Longxin Chemical Co. Ltd.
⚠️ Moderate Risk
FEI: 3009716224 • Zibo, Shandong • CHINA
FEI Number
3009716224
Location
Zibo, Shandong
Country
CHINAAddress
NO. 299 Yixi Road, Linzi District, Zibo, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2023 | 64XKS06SALICYLIC ACID (KERATOLYTIC) | 3845DRG REF EI | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Shandong Xinhua & Longxin Chemical Co. Ltd.'s FDA import refusal history?
Shandong Xinhua & Longxin Chemical Co. Ltd. (FEI: 3009716224) has 1 FDA import refusal record(s) in our database, spanning from 2/9/2023 to 2/9/2023.
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. Shandong Xinhua & Longxin Chemical Co. Ltd.'s FEI number is 3009716224.
What types of violations has Shandong Xinhua & Longxin Chemical Co. Ltd. received?
Shandong Xinhua & Longxin Chemical 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 Shandong Xinhua & Longxin Chemical Co. Ltd. come from?
All FDA import refusal data for Shandong Xinhua & Longxin Chemical 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.