Johnson & Johnson Ltd
⚠️ Moderate Risk
FEI: 1000278408 • Mumbai, Maharashtra • INDIA
FEI Number
1000278408
Location
Mumbai, Maharashtra
Country
INDIAAddress
30 Project St, , Mumbai, Maharashtra, 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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2013 | 62ADY04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/29/2013 | 66SDY05FLUNARIZINE HCL (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/21/2012 | 61TBA31DOMPERIDONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2011 | 85HHDPAD, MENSTRUAL, UNSCENTED | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/31/2009 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Johnson & Johnson Ltd's FDA import refusal history?
Johnson & Johnson Ltd (FEI: 1000278408) has 5 FDA import refusal record(s) in our database, spanning from 8/31/2009 to 11/29/2013.
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. Johnson & Johnson Ltd's FEI number is 1000278408.
What types of violations has Johnson & Johnson Ltd received?
Johnson & Johnson 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 Johnson & Johnson Ltd come from?
All FDA import refusal data for Johnson & Johnson 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.