Wendt-Chemie Vertriebsges Mbh & Co.
⚠️ High Risk
FEI: 3004850451 • Hamburg, Hamburg • GERMANY
FEI
FEI Number
3004850451
📍
Location
Hamburg, Hamburg
🇩🇪
Country
GERMANY🏢
Address
Wandsbeker Allee 72, , Hamburg, Hamburg, Germany
High Risk
FDA Import Risk Assessment
65.6
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
191
Total Refusals
4
Unique Violations
7/5/2016
Latest Refusal
12/9/2004
Earliest Refusal
Score Breakdown
Violation Severity
75.5×40%
Refusal Volume
84.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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
75151×
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).
11872×
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).
328013×
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.
1791×
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/5/2016 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 62ODZ12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 6/23/2016 | 64HDA99EXPECTORANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/22/2016 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 64BCS24FUROSEMIDE (DIURETIC) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 61XAL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 61KAB05ATROPINE SULFATE (ANTI-CHOLINERGIC) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Florida District Office (FLA-DO) | |
| 6/22/2016 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/22/2016 | 54ADB18VITAMIN K (PHYTONADIONE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/3/2016 | 62ODZ37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2016 | 62OAA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2016 | 64HBB05POTASSIUM GUAIACOLSULFONATE (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2016 | 60LAL21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2016 | 61WCA04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2016 | 55PP25BENZOIC ACID (PHARMACEUTIC NECESSITY - ANTIFUNGAL AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2016 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2016 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2016 | 62UAS99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/5/2016 | 64LAJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 4/5/2016 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2015 | 64HDA99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2015 | 54ADA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2015 | 64XAR06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2015 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/7/2015 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/7/2015 | 61XAL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/7/2015 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/10/2015 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/3/2015 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Florida District Office (FLA-DO) | |
| 4/3/2015 | 61GAA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Florida District Office (FLA-DO) | |
| 4/3/2015 | 61NAA69GABAPENTIN (ANTI-DEPRESSANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/3/2015 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/3/2015 | 61WCA04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/3/2015 | 75JKGL-ISOCITRATE AND NADP (U.V.), ISOCITRIC DEHYDROGENASE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/3/2015 | 64XBR06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/17/2015 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 60LAL21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 61KAB05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 54ADB18VITAMIN K (PHYTONADIONE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 54ADL13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 65QAL37AMINOPHYLLINE (RELAXANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 54ADB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 56AAA10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 61XAL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 56CAR25SODIUM CEPHALOTHIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/17/2015 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/13/2015 | 62RAJ07PARAROSANILINE PAMOATE (ANTI-SCHISTOSOMAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2015 | 55RG32LACTOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2015 | 55PP63GLYCERYL MONOSTEARATE (PHARMACEUTIC NECESSITY - EMULSIFYING AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2014 | 61FAB56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Florida District Office (FLA-DO) | |
| 10/2/2014 | 61NAA69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2014 | 54ABA22SODIUM ASCORBATE (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2014 | 65LDA06CALAMINE (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 5/14/2014 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 60LAL21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 64BCS24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 61XCL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2014 | 60SAL25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2014 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/24/2014 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2014 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2014 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/16/2013 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 56ICB76AZITHROMYCIN (MACAROLIDES) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 56CBZ25SODIUM CEPHALOTHIN (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 64BCS24FUROSEMIDE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 56CCA58CEFOPERAZONE SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 4/16/2013 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 10/17/2012 | 56CCA11CEFAZOLIN SODIUM (CEPHALOSPORINS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 64BCS24FUROSEMIDE (DIURETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2012 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/9/2012 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Southeast Imports (DSEI) | |
| 7/9/2012 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | Division of Southeast Imports (DSEI) | |
| 7/9/2012 | 64BCS24FUROSEMIDE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 7/9/2012 | 60LAL21DIPYRONE (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 7/9/2012 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 1/23/2012 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 56YYK99ANTIBIOTIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 54ADL18VITAMIN K (PHYTONADIONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/23/2011 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56AAA10PENICILLIN G, NATURAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wendt-Chemie Vertriebsges Mbh & Co.'s FDA import refusal history?
Wendt-Chemie Vertriebsges Mbh & Co. (FEI: 3004850451) has 191 FDA import refusal record(s) in our database, spanning from 12/9/2004 to 7/5/2016.
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. Wendt-Chemie Vertriebsges Mbh & Co.'s FEI number is 3004850451.
What types of violations has Wendt-Chemie Vertriebsges Mbh & Co. received?
Wendt-Chemie Vertriebsges Mbh & Co. 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 Wendt-Chemie Vertriebsges Mbh & Co. come from?
All FDA import refusal data for Wendt-Chemie Vertriebsges Mbh & Co. 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.