MEGAMIX
⚠️ High Risk
FEI: 3002752655 • Morelia • MEXICO
FEI Number
3002752655
Location
Morelia
Country
MEXICOAddress
Calle Antonio Alzate #71 Int. "A" Centro, , Morelia, , 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
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).
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 10/18/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 9/20/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 6/17/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/2/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 6/2/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 6/2/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 4/26/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 9/17/2004 | 53CH06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 9/17/2004 | 53CH06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 9/17/2004 | 53CH06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 6/17/2004 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 4/2/2004 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 4/2/2004 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 1/8/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 8/15/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/15/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/15/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/10/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/2/2002 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 12/2/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 12/2/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 11/4/2002 | 64AAL99DISINFECTANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is MEGAMIX's FDA import refusal history?
MEGAMIX (FEI: 3002752655) has 23 FDA import refusal record(s) in our database, spanning from 11/4/2002 to 10/18/2005.
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. MEGAMIX's FEI number is 3002752655.
What types of violations has MEGAMIX received?
MEGAMIX has been cited for 7 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 MEGAMIX come from?
All FDA import refusal data for MEGAMIX 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.