Delta Pharma Inc.
⚠️ Moderate Risk
FEI: 3003264747 • Dorval, Quebec • CANADA
FEI Number
3003264747
Location
Dorval, Quebec
Country
CANADAAddress
1655 Rte Transcanadienne, , Dorval, Quebec, 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
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).
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).
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
BSE DRUGS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2017 | 53LG10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/24/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/23/2016 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/23/2016 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 3/8/2016 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/29/2016 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/11/2014 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/28/2014 | 62HBY99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/28/2014 | 62HBY99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/28/2014 | 62HBY99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/7/2014 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 3761FILTH | New York District Office (NYK-DO) |
| 4/2/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 2840BSE DRUGS | New York District Office (NYK-DO) |
| 6/29/2012 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 304STERILITY | New York District Office (NYK-DO) |
| 2/25/2009 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 2/25/2009 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/29/2008 | 64XAL03BENZOYL PEROXIDE (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 4/29/2008 | 64XAL03BENZOYL PEROXIDE (KERATOLYTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Delta Pharma Inc.'s FDA import refusal history?
Delta Pharma Inc. (FEI: 3003264747) has 17 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 11/20/2017.
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. Delta Pharma Inc.'s FEI number is 3003264747.
What types of violations has Delta Pharma Inc. received?
Delta Pharma 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 Delta Pharma Inc. come from?
All FDA import refusal data for Delta Pharma 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.