Antwerp Shipping Pharmacy
⚠️ Moderate Risk
FEI: 1000459054 • 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
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 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 |
|---|---|---|---|
| 12/16/2011 | 79LRRKIT, FIRST AID | New England District Office (NWE-DO) | |
| 3/23/2005 | 65VCM15DIAZEPAM (SEDATIVE) | New York District Office (NYK-DO) | |
| 3/23/2005 | 62UCA08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Antwerp Shipping Pharmacy's FDA import refusal history?
Antwerp Shipping Pharmacy (FEI: 1000459054) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2005 to 12/16/2011.
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. Antwerp Shipping Pharmacy's FEI number is 1000459054.
What types of violations has Antwerp Shipping Pharmacy received?
Antwerp Shipping Pharmacy 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 Antwerp Shipping Pharmacy come from?
All FDA import refusal data for Antwerp Shipping Pharmacy 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.