Medpro Holland Bv
⚠️ Moderate Risk
FEI: 3003781256 • Scherpenzeel Gld, Gelderland • NETHERLANDS
FEI Number
3003781256
Location
Scherpenzeel Gld, Gelderland
Country
NETHERLANDSAddress
Dorpsstraat 182, , Scherpenzeel Gld, Gelderland, 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/13/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Cincinnati District Office (CIN-DO) |
| 11/5/2002 | 63XBF99DIAGOSTIC AID (DRUGS) N.E.C. | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medpro Holland Bv's FDA import refusal history?
Medpro Holland Bv (FEI: 3003781256) has 3 FDA import refusal record(s) in our database, spanning from 11/5/2002 to 4/14/2005.
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. Medpro Holland Bv's FEI number is 3003781256.
What types of violations has Medpro Holland Bv received?
Medpro Holland Bv has been cited for 4 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 Medpro Holland Bv come from?
All FDA import refusal data for Medpro Holland Bv 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.