Meyer Organics Pvt Ltd
⚠️ Moderate Risk
FEI: 3011277113 • Karnataka • INDIA
FEI Number
3011277113
Location
Karnataka
Country
INDIAAddress
10d 2nd Phase, Peenya Ind Area, , Karnataka, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2017 | 61XDL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/19/2017 | 61VDY01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 60CDA09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2017 | 61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 3/13/2017 | 61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 6/30/2016 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Meyer Organics Pvt Ltd's FDA import refusal history?
Meyer Organics Pvt Ltd (FEI: 3011277113) has 6 FDA import refusal record(s) in our database, spanning from 6/30/2016 to 9/8/2017.
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 Pvt Ltd's FEI number is 3011277113.
What types of violations has Meyer Organics Pvt Ltd received?
Meyer Organics Pvt Ltd has been cited for 4 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 Pvt Ltd come from?
All FDA import refusal data for Meyer Organics Pvt 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.