Cobeco Pharma Wholesale
⚠️ Moderate Risk
FEI: 3010945427 • Rotterdam, Zuid-holland • NETHERLANDS
FEI Number
3010945427
Location
Rotterdam, Zuid-holland
Country
NETHERLANDSAddress
Cairostraat 123-125, , Rotterdam, Zuid-holland, Netherlands
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
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).
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).
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.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 6/8/2016 | 66SCO99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2016 | 66SBY99VASODILATOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 55QY16GLYCERIN (PHARMACEUTIC NECESSITY - HUMECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2014 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cobeco Pharma Wholesale's FDA import refusal history?
Cobeco Pharma Wholesale (FEI: 3010945427) has 7 FDA import refusal record(s) in our database, spanning from 8/15/2014 to 7/26/2016.
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. Cobeco Pharma Wholesale's FEI number is 3010945427.
What types of violations has Cobeco Pharma Wholesale received?
Cobeco Pharma Wholesale has been cited for 9 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 Cobeco Pharma Wholesale come from?
All FDA import refusal data for Cobeco Pharma Wholesale 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.