Meyer Organics, LTD
⚠️ Moderate Risk
FEI: 3003578739 • Thane-400 604 (Mumbai) • INDIA
FEI Number
3003578739
Location
Thane-400 604 (Mumbai)
Country
INDIAAddress
A-177, Wagle Estate, Thane-400 604 (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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2019 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2018 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61XBC14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/15/2016 | 66BBK99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2016 | 66BBK99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2014 | 61XBY14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/9/2010 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Meyer Organics, LTD's FDA import refusal history?
Meyer Organics, LTD (FEI: 3003578739) has 7 FDA import refusal record(s) in our database, spanning from 11/9/2010 to 9/3/2019.
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. Meyer Organics, LTD's FEI number is 3003578739.
What types of violations has Meyer Organics, LTD received?
Meyer Organics, 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 Meyer Organics, LTD come from?
All FDA import refusal data for Meyer Organics, 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.