CMI Cosmetic Manufacturers Inc.
⚠️ High Risk
FEI: 3003420009 • Concord, On • CANADA
FEI
FEI Number
3003420009
📍
Location
Concord, On
🇨🇦
Country
CANADA🏢
Address
90 Moyal Court, , Concord, On, Canada
High Risk
FDA Import Risk Assessment
67.4
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
123
Total Refusals
5
Unique Violations
6/12/2015
Latest Refusal
10/21/2005
Earliest Refusal
Score Breakdown
Violation Severity
85.4×40%
Refusal Volume
77.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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
75111×
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).
11812×
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).
3444×
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
162×
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.
32802×
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/12/2015 | 61HBY99ANTI-BACTERIAL, N.E.C. | Detroit District Office (DET-DO) | |
| 6/12/2015 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 6/8/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Detroit District Office (DET-DO) | |
| 10/3/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/3/2011 | 62SBL99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/3/2011 | 56KBL99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 11/30/2010 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/30/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/30/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 12/10/2009 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/21/2005 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/21/2005 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is CMI Cosmetic Manufacturers Inc.'s FDA import refusal history?
CMI Cosmetic Manufacturers Inc. (FEI: 3003420009) has 123 FDA import refusal record(s) in our database, spanning from 10/21/2005 to 6/12/2015.
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. CMI Cosmetic Manufacturers Inc.'s FEI number is 3003420009.
What types of violations has CMI Cosmetic Manufacturers Inc. received?
CMI Cosmetic Manufacturers Inc. 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 CMI Cosmetic Manufacturers Inc. come from?
All FDA import refusal data for CMI Cosmetic Manufacturers Inc. 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.