International Custom Pak Inc.
⚠️ Moderate Risk
FEI: 3003301354 • Beamsville, Ontario • CANADA
FEI Number
3003301354
Location
Beamsville, Ontario
Country
CANADAAddress
4800 Hinan Dr, , Beamsville, Ontario, Canada
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
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).
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).
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).
EXPIRED
the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2012 | 64AAK99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 10/9/2012 | 80LJLDETECTORS AND REMOVERS, LICE, (INCLUDING COMBS) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 10/9/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/9/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 10/9/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/18/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/18/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/5/2003 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) | |
| 12/27/2002 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) | |
| 12/27/2002 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) | |
| 12/27/2002 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) | |
| 12/27/2002 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is International Custom Pak Inc.'s FDA import refusal history?
International Custom Pak Inc. (FEI: 3003301354) has 12 FDA import refusal record(s) in our database, spanning from 12/27/2002 to 11/9/2012.
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. International Custom Pak Inc.'s FEI number is 3003301354.
What types of violations has International Custom Pak Inc. received?
International Custom Pak Inc. 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 International Custom Pak Inc. come from?
All FDA import refusal data for International Custom Pak 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.