Amstelfarma
⚠️ Moderate Risk
FEI: 3003541837 • Heemstede, Noord-Holland • NETHERLANDS
FEI Number
3003541837
Location
Heemstede, Noord-Holland
Country
NETHERLANDSAddress
Postbus 38, , Heemstede, Noord-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
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2002 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/21/2002 | 60TDA05CIMETIDINE (ANTAGONIST) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2002 | 56YDA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2002 | 56EDB20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Amstelfarma's FDA import refusal history?
Amstelfarma (FEI: 3003541837) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2002 to 3/21/2002.
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. Amstelfarma's FEI number is 3003541837.
What types of violations has Amstelfarma received?
Amstelfarma 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 Amstelfarma come from?
All FDA import refusal data for Amstelfarma 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.