Rl Chemical
⚠️ Moderate Risk
FEI: 1000428794 • Mumbai • INDIA
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/13/2010 | 66SCS39CYCLANDELATE (VASODILATOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/17/2010 | 61HAS31METHENAMINE MANDELATE (ANTI-BACTERIAL) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/9/2004 | 66SCS39CYCLANDELATE (VASODILATOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rl Chemical's FDA import refusal history?
Rl Chemical (FEI: 1000428794) has 3 FDA import refusal record(s) in our database, spanning from 8/9/2004 to 5/13/2010.
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. Rl Chemical's FEI number is 1000428794.
What types of violations has Rl Chemical received?
Rl Chemical has been cited for 3 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 Rl Chemical come from?
All FDA import refusal data for Rl Chemical 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.