Chemo S.A. Lugano Branch
⚠️ High Risk
FEI: 3005144955 • Lugano, Ticino • SWITZERLAND
FEI
FEI Number
3005144955
📍
Location
Lugano, Ticino
🇨🇭
Country
SWITZERLAND🏢
Address
Via F. Pelli 17, , Lugano, Ticino, Switzerland
High Risk
FDA Import Risk Assessment
66.6
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
183
Total Refusals
4
Unique Violations
7/25/2016
Latest Refusal
6/14/2005
Earliest Refusal
Score Breakdown
Violation Severity
78.6×40%
Refusal Volume
83.9×30%
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
75171×
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).
11855×
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).
37416×
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.
32803×
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 |
|---|---|---|---|
| 7/25/2016 | 62CDA68OLMESARTAN MEDOXOMIL | Division of Southeast Imports (DSEI) | |
| 7/25/2016 | 62ODZ19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 7/25/2016 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 7/25/2016 | 62CAR41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 7/25/2016 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 7/25/2016 | 60XCS17ATENOLOL (ANTI-ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 4/26/2016 | 66SAA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2016 | 63BCB35CLENBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2016 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2016 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2016 | 61NAA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2016 | 66MCB36HALOPERIDOL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2016 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 61NAA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 62CAA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 62OAB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 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) |
| 3/19/2015 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2015 | 60XCS17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2015 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/3/2015 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/16/2015 | 60LCL99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/16/2015 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/16/2015 | 56CCA11CEFAZOLIN SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/16/2015 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/16/2015 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/13/2015 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 1/6/2015 | 54ADA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/6/2015 | 61XAL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/6/2015 | 60LAA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 61FAB56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/21/2014 | 61MAA11MAGNESIUM SULFATE (ANTI-CONVULSANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/5/2014 | 54ADL13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2014 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2014 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 6/3/2014 | 61WCA04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Florida District Office (FLA-DO) | |
| 6/3/2014 | 64HDA99EXPECTORANT N.E.C. | Florida District Office (FLA-DO) | |
| 6/3/2014 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Florida District Office (FLA-DO) | |
| 6/3/2014 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 6/3/2014 | 60XCS17ATENOLOL (ANTI-ADRENERGIC) | Florida District Office (FLA-DO) | |
| 5/27/2014 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/7/2014 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 4/14/2014 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/1/2014 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/24/2014 | 62ODS20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/24/2014 | 62UDA14LEVOPROPOXYPHENE NAPSYLATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/5/2013 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 6/5/2013 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 4/26/2013 | 56BAL09AMPICILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2013 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2013 | 61JAA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2013 | 61HAB43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/28/2013 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 3/28/2013 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 1/31/2013 | 64UBA04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | Division of Southeast Imports (DSEI) | |
| 1/9/2013 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2013 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 1/7/2013 | 61WBB18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 1/7/2013 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 1/7/2013 | 61WAB55TIOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 1/7/2013 | 61WAB99A-FUNGAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/27/2012 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2012 | 64BCS24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2012 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2012 | 60XCS17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2012 | 62UBA11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Southeast Imports (DSEI) | |
| 11/23/2012 | 61NAA69GABAPENTIN (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 11/23/2012 | 62ODZ12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 11/13/2012 | 61PAA31GLIMEPIRIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 10/25/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/24/2012 | 62ODZ37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/12/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 9/12/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 9/12/2012 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 9/12/2012 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 9/12/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 64HDA99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 62KAA99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 61TAA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 62FAA13FURAZOLIDONE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 61XDA09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 60LAA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 62OBA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2012 | 61LAA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 7/13/2012 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2012 | 61ECS99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2012 | 61ECS99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2011 | 62UAS99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2011 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/20/2011 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) | |
| 12/20/2011 | 63BAA99BRONCHODILATOR N.E.C. | Florida District Office (FLA-DO) | |
| 12/4/2011 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | Florida District Office (FLA-DO) | |
| 12/4/2011 | 56ICB76AZITHROMYCIN (MACAROLIDES) | Florida District Office (FLA-DO) | |
| 12/4/2011 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | Florida District Office (FLA-DO) | |
| 12/4/2011 | 60XCS17ATENOLOL (ANTI-ADRENERGIC) | Florida District Office (FLA-DO) | |
| 12/4/2011 | 64BCS24FUROSEMIDE (DIURETIC) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Chemo S.A. Lugano Branch's FDA import refusal history?
Chemo S.A. Lugano Branch (FEI: 3005144955) has 183 FDA import refusal record(s) in our database, spanning from 6/14/2005 to 7/25/2016.
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. Chemo S.A. Lugano Branch's FEI number is 3005144955.
What types of violations has Chemo S.A. Lugano Branch received?
Chemo S.A. Lugano Branch 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 Chemo S.A. Lugano Branch come from?
All FDA import refusal data for Chemo S.A. Lugano Branch 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.