Mission Hills, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3001119986 • San Jose Iturbide, Guanajuato • MEXICO
FEI Number
3001119986
Location
San Jose Iturbide, Guanajuato
Country
MEXICOAddress
Bicentenario Avenue N. 374, , San Jose Iturbide, Guanajuato, 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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/23/2018 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 11/14/2017 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 198COLOR LBLG | Division of Southwest Imports (DSWI) |
| 11/13/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
| 4/12/2016 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Florida District Office (FLA-DO) | |
| 4/12/2016 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Florida District Office (FLA-DO) | |
| 4/12/2016 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Florida District Office (FLA-DO) | |
| 4/12/2016 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Florida District Office (FLA-DO) | |
| 3/10/2016 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/10/2016 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/10/2016 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/13/2015 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 4/30/2015 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2015 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Southwest Import District Office (SWI-DO) | |
| 10/24/2014 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 8/5/2014 | 53JA04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/5/2014 | 53JA04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 9/10/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/10/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/10/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/10/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/10/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/8/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/7/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/7/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/6/2011 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/6/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/5/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/29/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/29/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/29/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/15/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/15/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/15/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/4/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/28/2011 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/15/2010 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mission Hills, S.A. de C.V.'s FDA import refusal history?
Mission Hills, S.A. de C.V. (FEI: 3001119986) has 41 FDA import refusal record(s) in our database, spanning from 7/15/2010 to 2/23/2018.
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. Mission Hills, S.A. de C.V.'s FEI number is 3001119986.
What types of violations has Mission Hills, S.A. de C.V. received?
Mission Hills, S.A. de C.V. has been cited for 9 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 Mission Hills, S.A. de C.V. come from?
All FDA import refusal data for Mission Hills, S.A. 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.