Shanghai Realy Chemical Co Ltd
⚠️ High Risk
FEI: 3007559718 • Shanghai • CHINA
FEI Number
3007559718
Location
Shanghai
Country
CHINAAddress
22g N6 Building1369 Dongfang, , Shanghai, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 6/14/2016 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2016 | 65LDA06CALAMINE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 50BGY30COLOR FOR DRUG (NOT CERTIFIED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/2/2016 | 62OCB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shanghai Realy Chemical Co Ltd's FDA import refusal history?
Shanghai Realy Chemical Co Ltd (FEI: 3007559718) has 7 FDA import refusal record(s) in our database, spanning from 5/2/2016 to 6/14/2016.
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. Shanghai Realy Chemical Co Ltd's FEI number is 3007559718.
What types of violations has Shanghai Realy Chemical Co Ltd received?
Shanghai Realy 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 Shanghai Realy Chemical Co Ltd come from?
All FDA import refusal data for Shanghai Realy 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.