Amstelfarma Bv
⚠️ High Risk
FEI: 3004637827 • Heemstede, Noord-Holland • NETHERLANDS
FEI Number
3004637827
Location
Heemstede, Noord-Holland
Country
NETHERLANDSAddress
Nijverheidsweg 37, , Heemstede, Noord-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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2014 | 61TAY29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/3/2014 | 66VAC99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 61KCL05ATROPINE SULFATE (ANTI-CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62LCA30MEFLOQUINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 56ICA10ERYTHROMYCIN (MACROLIDES) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 56CCL72CEFUROXIME SODIUM (CEPHALOSPORINS) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64LCJ37HYDROCORTISONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62LCA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62LCA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62LCA44ATOVAQUONE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62FCJ38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64XAJ06SALICYLIC ACID (KERATOLYTIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 65FCL03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 64LCL02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 63BCL01ALBUTEROL (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62GCL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 62KCA05LOPERAMIDE (ANTI-PERISTALTIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 60CCL04EPINEPHRINE (ADRENERGIC) | New Orleans District Office (NOL-DO) | |
| 7/25/2014 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amstelfarma Bv's FDA import refusal history?
Amstelfarma Bv (FEI: 3004637827) has 22 FDA import refusal record(s) in our database, spanning from 7/25/2014 to 9/3/2014.
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. Amstelfarma Bv's FEI number is 3004637827.
What types of violations has Amstelfarma Bv received?
Amstelfarma Bv 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 Bv come from?
All FDA import refusal data for Amstelfarma Bv 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.