Mead Johnson & Company, LLC
⚠️ Moderate Risk
FEI: 1819504 • Evansville, IN • UNITED STATES
FEI Number
1819504
Location
Evansville, IN
Country
UNITED STATESAddress
2400 W Lloyd Expy, , Evansville, IN, United States
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).
FORBIDDEN
The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NUTR UNIT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2008 | 62VCE53REYATAZ | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 6/19/2008 | 62VCF49VIDEX EC (ANTI-VIRAL) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 6/19/2008 | 62VCF49VIDEX EC (ANTI-VIRAL) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 11/19/2007 | 40CED01MILK BASE FORMULA PRODUCT (BABY) | 3362NUTR UNIT | San Juan District Office (SJN-DO) |
| 10/26/2007 | 66NCA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/2/2007 | 40CEO01MILK BASE FORMULA PRODUCT (BABY) | New York District Office (NYK-DO) | |
| 10/6/2005 | 40CEH01MILK BASE FORMULA PRODUCT (BABY) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mead Johnson & Company, LLC's FDA import refusal history?
Mead Johnson & Company, LLC (FEI: 1819504) has 7 FDA import refusal record(s) in our database, spanning from 10/6/2005 to 6/19/2008.
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. Mead Johnson & Company, LLC's FEI number is 1819504.
What types of violations has Mead Johnson & Company, LLC received?
Mead Johnson & Company, LLC has been cited for 6 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 Mead Johnson & Company, LLC come from?
All FDA import refusal data for Mead Johnson & Company, LLC 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.