Carnival Cruise Lines
⚠️ High Risk
FEI: 3004567236 • Freeport City • BAHAMAS
FEI
FEI Number
3004567236
📍
Location
Freeport City
🇧🇸
Country
BAHAMAS🏢
Address
PO Box 42498, , Freeport City, , Bahamas
High Risk
FDA Import Risk Assessment
64.5
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
119
Total Refusals
4
Unique Violations
12/23/2011
Latest Refusal
6/9/2009
Earliest Refusal
Score Breakdown
Violation Severity
78.5×40%
Refusal Volume
77.0×30%
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
3380115×
EXPIRED
the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.
3413×
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
5081×
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2011 | 63BAY01ALBUTEROL (BRONCHODILATOR) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 64SAY08ETOMIDATE (HYPNOTIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60QAY99ANESTHETIC, N.E.C. | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 62LAY52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 65RAY14POTASSIUM CHLORIDE (REPLENISHER) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 64LAY19DEXAMETHASONE (GLUCOCORTICOID) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61FAY34ERTHROMYCIN PROPIONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61GAY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 62OAY26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 64BAY24FUROSEMIDE (DIURETIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60QAY82FLUMAZENIL (ANESTHETIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 63EAY18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 63FAY06DIGOXIN (CARDIOTONIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61MAY11MAGNESIUM SULFATE (ANTI-CONVULSANT) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 62OAY26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 56DAY20GENTAMICIN (AMINOGLYCOSIDES) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61TAY20TRIMETHOBENZAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61LAY29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 56IAY76AZITHROMYCIN (MACAROLIDES) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 63EAY30TIROFIBAN HCL (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60CBY04EPINEPHRINE (ADRENERGIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 61PAY10GLUCAGON (ANTI-DIABETIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60QAY07LIDOCAINE | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60CBY04EPINEPHRINE (ADRENERGIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60CBY04EPINEPHRINE (ADRENERGIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60CBY04EPINEPHRINE (ADRENERGIC) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 63EAY19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 12/23/2011 | 60SAY23METOCLOPRAMIDE (ANTACID) | 3380EXPIRED | Seattle District Office (SEA-DO) |
| 11/17/2011 | 62OAY24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63BAY01ALBUTEROL (BRONCHODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64LAY19DEXAMETHASONE (GLUCOCORTICOID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62CAY30HYDRALAZINE HCL (ANTI-HYPERTENSIVE) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64BAY24FUROSEMIDE (DIURETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64LAY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 66SAY36VERAPAMIL (VASODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63HAY01BISACODYL (CATHARTIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 66MAY85KETAZOLAM (TRANQUILIZER) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64BAY40TRIAMTERENE (DIURETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64BAY40TRIAMTERENE (DIURETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60SAY23METOCLOPRAMIDE (ANTACID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 56ACY99PENICILLIN NATURAL, N.E.C. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62OAY47MOEXIPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63EAY16QUINIDINE GLUCONATE (CARDIAC DEPRESSANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61XAY18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61NAY29FLUOXETINE (ANTI-DEPRESSANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62VAY01AMANTADINE HCL (ANTI-VIRAL) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 56CAY99CEPHALOSPORIN N.E.C. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60QCK07LIDOCAINE | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 65QAY37AMINOPHYLLINE (RELAXANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62OAY39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63BCQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60LCC88SUMATRIPTAN (ANALGESIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61GCK85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64LAY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 56BAY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63BAY01ALBUTEROL (BRONCHODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60SAY25RANITIDINE HYDROCHLORIDE (ANTACID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61LAY20ANTI-COAGULANT CITRATE DEXTROSE SOLUTION | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63BCQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62CAY65LISINOPRIL (ANTI-HYPERTENSIVE) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61LCE38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 65RAY12POTASSIC SALINE (INJECTION) (REPLENISHER) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 66SAY28NITROGLYCERIN (TAB) (VASODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63BCQ26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61TAY03CHLORPROMAZINE (ANTI-EMETIC/NAUSEANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61TAY14PROCHLORPERAZINE (ANTI-EMETIC/NAUSEANT) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62CAY30HYDRALAZINE HCL (ANTI-HYPERTENSIVE) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64LAY19DEXAMETHASONE (GLUCOCORTICOID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63ECB18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63FAY06DIGOXIN (CARDIOTONIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61XAY18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61XAY18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61PAY58INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 66MAY98HALOPERIDOL DECANOATE (TRANQUILIZER, ANTI-PSYCHOTIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 64RAY16VASOPRESSIN (INJ) (HORMONE) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60QAY82FLUMAZENIL (ANESTHETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 63NAY07NEOSTIGMINE BROMIDE (CHOLINERGIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60CCK32EPINEPHRINE BITARTRATE (ADRENERGIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 60SDY22FAMOTIDINE (ANTACID) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 61PAF09GLIPIZIDE (ANTI-DIABETIC) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 11/17/2011 | 62CAY30HYDRALAZINE HCL (ANTI-HYPERTENSIVE) | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
| 5/17/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3380EXPIRED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Carnival Cruise Lines's FDA import refusal history?
Carnival Cruise Lines (FEI: 3004567236) has 119 FDA import refusal record(s) in our database, spanning from 6/9/2009 to 12/23/2011.
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. Carnival Cruise Lines's FEI number is 3004567236.
What types of violations has Carnival Cruise Lines received?
Carnival Cruise Lines 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 Carnival Cruise Lines come from?
All FDA import refusal data for Carnival Cruise Lines 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.