Medica International Pharmaceutical
✅ Low Risk
FEI: 3005336415 • Putte, Noord-Brabant • NETHERLANDS
FEI Number
3005336415
Location
Putte, Noord-Brabant
Country
NETHERLANDSAddress
Postbus 79, , Putte, Noord-Brabant, Netherlands
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2005 | 54YCF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 10/24/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medica International Pharmaceutical's FDA import refusal history?
Medica International Pharmaceutical (FEI: 3005336415) has 2 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 10/24/2005.
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. Medica International Pharmaceutical's FEI number is 3005336415.
What types of violations has Medica International Pharmaceutical received?
Medica International Pharmaceutical has been cited for 3 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 Medica International Pharmaceutical come from?
All FDA import refusal data for Medica International Pharmaceutical 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.