Pharmachemie B.V. dba Teva Pharmachemie
⚠️ High Risk
FEI: 3002807910 • Haarlem, Noord-Holland • NETHERLANDS
FEI Number
3002807910
Location
Haarlem, Noord-Holland
Country
NETHERLANDSAddress
Swensweg 5, , Haarlem, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 61HCY43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2026 | 66BCA48LISDEXAMFETAMINE (STIMULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/27/2023 | 66NDY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/13/2022 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2021 | 66NDB02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/23/2020 | 62ICP77ETOPOSIDE (ANTI-NEOPLASTIC) | Division of Northeast Imports (DNEI) | |
| 2/15/2019 | 62JCY01BENZTROPINE MESYLATE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/13/2013 | 64FIY99ENZYME INHIBITOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/13/2013 | 55QP52DILUTED ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | New Orleans District Office (NOL-DO) | |
| 10/28/2011 | 63BCQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 62IIS79FLUDARABINE PHOSPHATE (ANTI-NEOPLASTIC) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 64SCB09FLUNITRAZEPAM (HYPNOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/17/2005 | 56HDK24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 9/13/2005 | 62LCE40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmachemie B.V. dba Teva Pharmachemie's FDA import refusal history?
Pharmachemie B.V. dba Teva Pharmachemie (FEI: 3002807910) has 14 FDA import refusal record(s) in our database, spanning from 9/13/2005 to 1/22/2026.
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. Pharmachemie B.V. dba Teva Pharmachemie's FEI number is 3002807910.
What types of violations has Pharmachemie B.V. dba Teva Pharmachemie received?
Pharmachemie B.V. dba Teva Pharmachemie 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 Pharmachemie B.V. dba Teva Pharmachemie come from?
All FDA import refusal data for Pharmachemie B.V. dba Teva Pharmachemie 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.