Haleon Consumer Healthcare Mexico, S. de R.L. de C.V.
⚠️ High Risk
FEI: 3008320990 • Jiutepec, Morelos • MEXICO
FEI Number
3008320990
Location
Jiutepec, Morelos
Country
MEXICOAddress
Calle 21 Este No 104, Zona Industrial Civac, Jiutepec, Jiutepec, Morelos, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2023 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2023 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 62GDO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2018 | 62UCL01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2017 | 64LAO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southwest Imports (DSWI) | |
| 5/10/2012 | 55QY30WHITE OINTMENT (PHARMACEUTIC NECESSITY - OLEAGINOUS) | Southwest Import District Office (SWI-DO) | |
| 5/10/2012 | 55QY30WHITE OINTMENT (PHARMACEUTIC NECESSITY - OLEAGINOUS) | Southwest Import District Office (SWI-DO) | |
| 1/15/2008 | 56BDB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/30/2005 | 63XCE99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Haleon Consumer Healthcare Mexico, S. de R.L. de C.V.'s FDA import refusal history?
Haleon Consumer Healthcare Mexico, S. de R.L. de C.V. (FEI: 3008320990) has 11 FDA import refusal record(s) in our database, spanning from 11/30/2005 to 11/28/2023.
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. Haleon Consumer Healthcare Mexico, S. de R.L. de C.V.'s FEI number is 3008320990.
What types of violations has Haleon Consumer Healthcare Mexico, S. de R.L. de C.V. received?
Haleon Consumer Healthcare 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 Haleon Consumer Healthcare Mexico, S. de R.L. de C.V. come from?
All FDA import refusal data for Haleon Consumer Healthcare 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.