Nisim International
⚠️ Moderate Risk
FEI: 1000572906 • Brampton, Ontario • CANADA
FEI Number
1000572906
Location
Brampton, Ontario
Country
CANADAAddress
204 Wilkinson Rd, , Brampton, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2008 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 3/26/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 2/12/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/12/2008 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2007 | 62NBL99ANTI-PSORIATIC N.E.C. | New York District Office (NYK-DO) | |
| 7/13/2005 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/30/2004 | 55QP59ISOPROPYL ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | New York District Office (NYK-DO) | |
| 7/30/2004 | 55QP59ISOPROPYL ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | New York District Office (NYK-DO) | |
| 7/30/2004 | 55QP59ISOPROPYL ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nisim International's FDA import refusal history?
Nisim International (FEI: 1000572906) has 16 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 3/26/2008.
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. Nisim International's FEI number is 1000572906.
What types of violations has Nisim International received?
Nisim International 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 Nisim International come from?
All FDA import refusal data for Nisim International 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.