DUFRY CRUISE SERVICES INC
⚠️ High Risk
FEI: 3015862244 • Miami, FL • UNITED STATES
FEI Number
3015862244
Location
Miami, FL
Country
UNITED STATESAddress
13690 Nw 14th St, , Miami, FL, United States
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2021 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 80MMSLUBRICANT, VAGINAL, PATIENT | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 76JESFLOSS, DENTAL | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 85HISCONDOM | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DUFRY CRUISE SERVICES INC's FDA import refusal history?
DUFRY CRUISE SERVICES INC (FEI: 3015862244) has 32 FDA import refusal record(s) in our database, spanning from 7/13/2021 to 7/13/2021.
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. DUFRY CRUISE SERVICES INC's FEI number is 3015862244.
What types of violations has DUFRY CRUISE SERVICES INC received?
DUFRY CRUISE SERVICES INC 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 DUFRY CRUISE SERVICES INC come from?
All FDA import refusal data for DUFRY CRUISE SERVICES INC 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.