Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3004317032 • Delicias, Chihuahua • MEXICO
FEI Number
3004317032
Location
Delicias, Chihuahua
Country
MEXICOAddress
Carretera Panamericana Km 1573, Col. Ciudad Delicias Centro, Delicias, Delicias, Chihuahua, Mexico
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).
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)).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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 |
|---|---|---|---|
| 6/20/2012 | 56ECA99TETRACYCLINE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2008 | 30YGT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | Florida District Office (FLA-DO) | |
| 4/13/2007 | 56BBF09AMPICILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2006 | 56BAB05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/6/2005 | 40CEH01MILK BASE FORMULA PRODUCT (BABY) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 9/15/2005 | 62OQY37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/25/2002 | 34HFT99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 11/20/2001 | 62UBJ01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V.'s FDA import refusal history?
Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. (FEI: 3004317032) has 8 FDA import refusal record(s) in our database, spanning from 11/20/2001 to 6/20/2012.
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 Nutricionales de Mexico, S. de R.L. de C.V.'s FEI number is 3004317032.
What types of violations has Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. received?
Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. has been cited for 5 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 Nutricionales de Mexico, S. de R.L. de C.V. come from?
All FDA import refusal data for Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. 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.