Laboratoria Qualiphar NV
⚠️ Moderate Risk
FEI: 1000627334 • Bornem, Antwerp • BELGIUM
FEI Number
1000627334
Location
Bornem, Antwerp
Country
BELGIUMAddress
Rijksweg 9, , Bornem, Antwerp, Belgium
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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2024 | 60QAJ56BENZOCAINE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 7/18/2019 | 66FBL99SUPPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/21/2015 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | New Orleans District Office (NOL-DO) | |
| 5/11/2006 | 65CRA99NUTRIENT/TONIC N.E.C. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 5/11/2006 | 65CRA99NUTRIENT/TONIC N.E.C. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratoria Qualiphar NV's FDA import refusal history?
Laboratoria Qualiphar NV (FEI: 1000627334) has 5 FDA import refusal record(s) in our database, spanning from 5/11/2006 to 1/31/2024.
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. Laboratoria Qualiphar NV's FEI number is 1000627334.
What types of violations has Laboratoria Qualiphar NV received?
Laboratoria Qualiphar NV 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 Laboratoria Qualiphar NV come from?
All FDA import refusal data for Laboratoria Qualiphar NV 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.