BASF SE
⚠️ High Risk
FEI: 3002903906 • Ludwigshafen Am Rhein, Rhineland-Palatinate • GERMANY
FEI Number
3002903906
Location
Ludwigshafen Am Rhein, Rhineland-Palatinate
Country
GERMANYAddress
Carl-Bosch-Str. 38, , Ludwigshafen Am Rhein, Rhineland-Palatinate, Germany
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2022 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2022 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2017 | 55RP32LACTOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/19/2014 | 63NAS04DEXPANTHENOL (CHOLINERGIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/18/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/12/2013 | 64AAS20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 8/13/2013 | 66PAY09PADIMATE O (ULTRAVIOLET SCREEN/SUNSCREEN) | New York District Office (NYK-DO) | |
| 8/13/2013 | 66PAY09PADIMATE O (ULTRAVIOLET SCREEN/SUNSCREEN) | New York District Office (NYK-DO) | |
| 8/15/2012 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2012 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2012 | 55PP54POVIDONE (PHARMACEUTIC NECESSITY - DISPERSING & SUSPENDING AGENT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2012 | 55PP54POVIDONE (PHARMACEUTIC NECESSITY - DISPERSING & SUSPENDING AGENT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2012 | 55PP57OLEYL ALCOHOL (PHARMACEUTIC NECESSITY - EMOLLIENT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/15/2012 | 55PP57OLEYL ALCOHOL (PHARMACEUTIC NECESSITY - EMOLLIENT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/29/2012 | 63FCS08DOBUTAMINE HCL (CARDIOTONIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/29/2012 | 63FCS08DOBUTAMINE HCL (CARDIOTONIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2012 | 65QCS37AMINOPHYLLINE (RELAXANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/9/2011 | 64XAY07TRETINOIN (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 7/27/2011 | 63BCS30THEOPHYLLINE (BRONCHODILATOR) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/23/2010 | 64XCY11ISOTRETINOIN (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/9/2009 | 62JCR18SELEGILINE HYDROCHLORIDE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/30/2009 | 66PAR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/19/2008 | 64XAY07TRETINOIN (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 7/13/2006 | 60CCS53XYLOMETAZOLINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 6/7/2006 | 64XAY07TRETINOIN (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/19/2005 | 64XAR07TRETINOIN (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/19/2005 | 64XAR07TRETINOIN (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/19/2005 | 64XAY07TRETINOIN (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/2/2005 | 60QCS52TETRACAINE HCL (ANESTHETIC) | New York District Office (NYK-DO) | |
| 10/1/2004 | 64XAY07TRETINOIN (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 12/21/2001 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BASF SE's FDA import refusal history?
BASF SE (FEI: 3002903906) has 47 FDA import refusal record(s) in our database, spanning from 12/21/2001 to 9/2/2022.
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. BASF SE's FEI number is 3002903906.
What types of violations has BASF SE received?
BASF SE 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 BASF SE come from?
All FDA import refusal data for BASF SE 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.