Mosadex
⚠️ High Risk
FEI: 3010877654 • Leiden, Zuid-holland • NETHERLANDS
FEI Number
3010877654
Location
Leiden, Zuid-holland
Country
NETHERLANDSAddress
Nieuwenhuizenweg 17, , Leiden, Zuid-holland, Netherlands
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2014 | 79EFQSPONGE, GAUZE | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 80FQMBANDAGE, ELASTIC | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 79MGOCLOSURE, WOUND, ADHESIVE | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 79EYFPROTECTOR, WOUND, PLASTIC | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62FCL08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64LCL19DEXAMETHASONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 56KCL10CHLORAMPHENICOL | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 56KCJ10CHLORAMPHENICOL | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64LCA50PREDNISOLONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60SCL14MAGNESIUM HYDROXIDE (ANTACID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 63NCL21PILOCARPINE HCL (CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62LCJ52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 61TCL17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60LCL69TRAMADOL HCL (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60LCL69TRAMADOL HCL (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60BAA01AMMONIUM CHLORIDE (ACIDIFIER) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 61TCL17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60TCA05CIMETIDINE (ANTAGONIST) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64BCL24FUROSEMIDE (DIURETIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64BCA24FUROSEMIDE (DIURETIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 66SCL28NITROGLYCERIN (TAB) (VASODILATOR) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 55QP58GLYCERIN (PHARMACEUTIC NECESSITY - SOLVENT) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 54JDA03VALERIAN (HERBAL & BOTANICALS II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mosadex's FDA import refusal history?
Mosadex (FEI: 3010877654) has 26 FDA import refusal record(s) in our database, spanning from 7/25/2014 to 7/25/2014.
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. Mosadex's FEI number is 3010877654.
What types of violations has Mosadex received?
Mosadex 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 Mosadex come from?
All FDA import refusal data for Mosadex 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.