Carnival Corporation
⚠️ Moderate Risk
FEI: 1000321916 • Doral, FL • UNITED STATES
FEI Number
1000321916
Location
Doral, FL
Country
UNITED STATESAddress
3655 Nw 87th Ave, , Doral, FL, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2022 | 94RCGSECURITY X-RAY (INCLUDES BAGGAGE X-RAY), CABINET X-RAY SYSTEMS, NON-MEDICAL | Division of Southeast Imports (DSEI) | |
| 7/8/2015 | 95RECLASER VIDEO PROJECTOR, DISPLAY PRODUCTS | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 4/16/2014 | 81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/6/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Carnival Corporation's FDA import refusal history?
Carnival Corporation (FEI: 1000321916) has 4 FDA import refusal record(s) in our database, spanning from 8/6/2013 to 11/28/2022.
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. Carnival Corporation's FEI number is 1000321916.
What types of violations has Carnival Corporation received?
Carnival Corporation has been cited for 5 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 Corporation come from?
All FDA import refusal data for Carnival Corporation 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.