Comercializadora Quality Health S.A
⚠️ High Risk
FEI: 3009201645 • Zona Centro, Jal • MEXICO
FEI Number
3009201645
Location
Zona Centro, Jal
Country
MEXICOAddress
Fermin G Riestra 43, , Zona Centro, Jal, 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 6/6/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 4/30/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 11/21/2012 | 54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 7/20/2012 | 54ICR99FIBER, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 7/12/2012 | 55QY26HYDROPHILIC PETROLATUM (PHARMACEUTIC NECESSITY - ABSORBENT) | Southwest Import District Office (SWI-DO) | |
| 7/12/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 6/22/2012 | 55QY26HYDROPHILIC PETROLATUM (PHARMACEUTIC NECESSITY - ABSORBENT) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 6/22/2012 | 55QY26HYDROPHILIC PETROLATUM (PHARMACEUTIC NECESSITY - ABSORBENT) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 6/12/2012 | 54YYH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/30/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 4/25/2012 | 55QY26HYDROPHILIC PETROLATUM (PHARMACEUTIC NECESSITY - ABSORBENT) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Comercializadora Quality Health S.A's FDA import refusal history?
Comercializadora Quality Health S.A (FEI: 3009201645) has 12 FDA import refusal record(s) in our database, spanning from 4/25/2012 to 6/6/2013.
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. Comercializadora Quality Health S.A's FEI number is 3009201645.
What types of violations has Comercializadora Quality Health S.A received?
Comercializadora Quality Health S.A has been cited for 10 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 Comercializadora Quality Health S.A come from?
All FDA import refusal data for Comercializadora Quality Health S.A 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.