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Canadian Custom Packaging Co.

⚠️ High Risk

FEI: 1000323280 • North York, Ontario • CANADA

FEI

FEI Number

1000323280

📍

Location

North York, Ontario

🇨🇦

Country

CANADA
🏢

Address

333 Rimrock Rd, , North York, Ontario, Canada

High Risk

FDA Import Risk Assessment

52.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

42
Total Refusals
6
Unique Violations
12/17/2014
Latest Refusal
6/17/2005
Earliest Refusal

Score Breakdown

Violation Severity
74.9×40%
Refusal Volume
60.5×30%
Recency
0.0×20%
Frequency
44.2×10%
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

7532×

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).

4737×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4757×

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.

111×

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).

1181×

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).

1971×

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).

Refusal History

DateProductViolationsDivision
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
12/17/2014
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Detroit District Office (DET-DO)
6/2/2011
53CD02EYELINER (EYE MAKEUP PREPARATIONS)
197COSM COLOR
New York District Office (NYK-DO)
2/8/2011
79LRRKIT, FIRST AID
118NOT LISTED
Seattle District Office (SEA-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
6/17/2005
33EYY99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Canadian Custom Packaging Co.'s FDA import refusal history?

Canadian Custom Packaging Co. (FEI: 1000323280) has 42 FDA import refusal record(s) in our database, spanning from 6/17/2005 to 12/17/2014.

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. Canadian Custom Packaging Co.'s FEI number is 1000323280.

What types of violations has Canadian Custom Packaging Co. received?

Canadian Custom Packaging Co. has been cited for 6 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 Canadian Custom Packaging Co. come from?

All FDA import refusal data for Canadian Custom Packaging Co. 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.