The Press Club Nutrition Ltd
⚠️ Moderate Risk
FEI: 3009108361 • Coquitlam, British Columbia • CANADA
FEI Number
3009108361
Location
Coquitlam, British Columbia
Country
CANADAAddress
3329 Thor Crt, , Coquitlam, British Columbia, 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
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).
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 |
|---|---|---|---|
| 1/17/2018 | 55PG64HYDRATED SILICA (PHARMACEUTIC NECESSITY - ABRASIVE) | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 55RG77COPOVIDONE (PHARMACEUTIC NECESSITY) | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 55YG99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/31/2017 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | New Orleans District Office (NOL-DO) | |
| 3/31/2017 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | Division of Southeast Imports (DSEI) | |
| 3/31/2017 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | New Orleans District Office (NOL-DO) | |
| 3/10/2017 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | New Orleans District Office (NOL-DO) | |
| 8/2/2016 | 55RP31MICROCRYSTALLINE CELLULOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is The Press Club Nutrition Ltd's FDA import refusal history?
The Press Club Nutrition Ltd (FEI: 3009108361) has 9 FDA import refusal record(s) in our database, spanning from 8/2/2016 to 1/17/2018.
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. The Press Club Nutrition Ltd's FEI number is 3009108361.
What types of violations has The Press Club Nutrition Ltd received?
The Press Club Nutrition Ltd 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 The Press Club Nutrition Ltd come from?
All FDA import refusal data for The Press Club Nutrition Ltd 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.