Crombie Kennedy Nasmark Inc.
⚠️ Moderate Risk
FEI: 3004103878 • Markham, Ontario • CANADA
FEI Number
3004103878
Location
Markham, Ontario
Country
CANADAAddress
151 Esna Park Dr Unit 4, , Markham, 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
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.
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2009 | 61SBJ01COAL TAR (ANTI-ECZEMATIC) | New York District Office (NYK-DO) | |
| 9/1/2009 | 61SAY01COAL TAR (ANTI-ECZEMATIC) | New York District Office (NYK-DO) | |
| 5/6/2004 | 63WBY99DETERGENT N.E.C. | New York District Office (NYK-DO) | |
| 5/6/2004 | 63WBJ99DETERGENT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Crombie Kennedy Nasmark Inc.'s FDA import refusal history?
Crombie Kennedy Nasmark Inc. (FEI: 3004103878) has 4 FDA import refusal record(s) in our database, spanning from 5/6/2004 to 9/1/2009.
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. Crombie Kennedy Nasmark Inc.'s FEI number is 3004103878.
What types of violations has Crombie Kennedy Nasmark Inc. received?
Crombie Kennedy Nasmark 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 Crombie Kennedy Nasmark Inc. come from?
All FDA import refusal data for Crombie Kennedy Nasmark 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.