G Production, Inc.
⚠️ Moderate Risk
FEI: 3003671557 • Baie-D'Urfe, Quebec • CANADA
FEI Number
3003671557
Location
Baie-D'Urfe, Quebec
Country
CANADAAddress
19400 Aut Transcanadienne, , Baie-D'Urfe, 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.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2018 | 61SBL99ANTI-ECZEMATIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 3/13/2018 | 61SBL99ANTI-ECZEMATIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/14/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 223FALSE | Division of Northern Border Imports (DNBI) |
| 6/8/2009 | 62SCS02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2008 | 62LCJ50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 342PERSONALRX | New Orleans District Office (NOL-DO) |
| 10/14/2003 | 62LDJ40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is G Production, Inc.'s FDA import refusal history?
G Production, Inc. (FEI: 3003671557) has 6 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 3/13/2018.
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. G Production, Inc.'s FEI number is 3003671557.
What types of violations has G Production, Inc. received?
G Production, Inc. 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 G Production, Inc. come from?
All FDA import refusal data for G Production, 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.