Provero Pharma B.V.
⚠️ Moderate Risk
FEI: 3014229766 • Schijndel, Noord-Brabant • NETHERLANDS
FEI Number
3014229766
Location
Schijndel, Noord-Brabant
Country
NETHERLANDSAddress
Madame Curieweg 7, , Schijndel, Noord-Brabant, 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
NCONTACT
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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2024 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/13/2024 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/13/2024 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2024 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/7/2023 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/10/2019 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/10/2019 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/10/2019 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/10/2019 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Provero Pharma B.V.'s FDA import refusal history?
Provero Pharma B.V. (FEI: 3014229766) has 9 FDA import refusal record(s) in our database, spanning from 5/10/2019 to 8/13/2024.
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. Provero Pharma B.V.'s FEI number is 3014229766.
What types of violations has Provero Pharma B.V. received?
Provero Pharma B.V. 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 Provero Pharma B.V. come from?
All FDA import refusal data for Provero Pharma B.V. 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.