Legaay International
⚠️ Moderate Risk
FEI: 3004723151 • Rotterdam, Zuid-Holland • NETHERLANDS
FEI Number
3004723151
Location
Rotterdam, Zuid-Holland
Country
NETHERLANDSAddress
Van Helmontstraat 99, , 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
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).
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 LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2014 | 57IH17MEASLES, MUMPS, RUBELLA VIRUS VACCINE | 71NO LICENSE | Los Angeles District Office (LOS-DO) |
| 3/3/2014 | 57CH21YELLOW FEVER VACCINE | 71NO LICENSE | Los Angeles District Office (LOS-DO) |
| 5/11/2006 | 80FMFSYRINGE, PISTON | New York District Office (NYK-DO) | |
| 5/11/2006 | 79KGXTAPE AND BANDAGE, ADHESIVE | New York District Office (NYK-DO) | |
| 5/11/2006 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | New York District Office (NYK-DO) | |
| 5/11/2006 | 80FMQRESTRAINT, PROTECTIVE | New York District Office (NYK-DO) | |
| 5/11/2006 | 89ITGBANDAGE, CAST | New York District Office (NYK-DO) | |
| 5/11/2006 | 79GEMGAUZE, ABSORBABLE | New York District Office (NYK-DO) | |
| 5/11/2006 | 62WAR03ALUMINUM ACETATE (SOL) (ASTRINGENT/ANTI-PERSPIRANT) | New York District Office (NYK-DO) | |
| 5/11/2006 | 62MBJ08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 5/11/2006 | 62FAK08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 5/11/2006 | 62FBK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 5/11/2006 | 60QCK67LIDOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 5/11/2006 | 56ECO80TETRACYCLINE (TETRACYCLINES) | New York District Office (NYK-DO) | |
| 5/11/2006 | 61XCM13CYCLIZINE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/11/2006 | 61TCP12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | New York District Office (NYK-DO) | |
| 5/11/2006 | 56YCO99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) | |
| 5/11/2006 | 65LBJ15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | New York District Office (NYK-DO) | |
| 5/11/2006 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | New York District Office (NYK-DO) | |
| 5/11/2006 | 62GAA41IBUPROFEN (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 5/11/2006 | 60LCA14CARBAMAZEPINE (ANALGESIC) | New York District Office (NYK-DO) | |
| 5/11/2006 | 61KCP05ATROPINE SULFATE (ANTI-CHOLINERGIC) | New York District Office (NYK-DO) | |
| 8/30/2005 | 79LRRKIT, FIRST AID | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Legaay International's FDA import refusal history?
Legaay International (FEI: 3004723151) has 23 FDA import refusal record(s) in our database, spanning from 8/30/2005 to 5/20/2014.
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. Legaay International's FEI number is 3004723151.
What types of violations has Legaay International received?
Legaay International 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 Legaay International come from?
All FDA import refusal data for Legaay International 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.