ONESPAWORLD (Bahamas) Limited
⚠️ Moderate Risk
FEI: 3000979022 • Miami, FL • UNITED STATES
FEI Number
3000979022
Location
Miami, FL
Country
UNITED STATESAddress
2323 Nw 82nd Ave, , Miami, 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).
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.
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2014 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | Florida District Office (FLA-DO) | |
| 7/25/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Florida District Office (FLA-DO) | |
| 7/3/2014 | 80FQASCALE, SURGICAL SPONGE | Florida District Office (FLA-DO) | |
| 7/3/2014 | 80OUKSURGICAL MASK WITH ANTIMICROBIAL/ANTIVIRAL AGENT | Florida District Office (FLA-DO) | |
| 5/22/2014 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Florida District Office (FLA-DO) |
| 5/22/2014 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Florida District Office (FLA-DO) |
| 5/22/2014 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Florida District Office (FLA-DO) | |
| 5/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Florida District Office (FLA-DO) | |
| 5/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Florida District Office (FLA-DO) | |
| 5/22/2014 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/5/2014 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/5/2014 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is ONESPAWORLD (Bahamas) Limited's FDA import refusal history?
ONESPAWORLD (Bahamas) Limited (FEI: 3000979022) has 13 FDA import refusal record(s) in our database, spanning from 5/5/2014 to 7/25/2014.
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. ONESPAWORLD (Bahamas) Limited's FEI number is 3000979022.
What types of violations has ONESPAWORLD (Bahamas) Limited received?
ONESPAWORLD (Bahamas) Limited has been cited for 6 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 ONESPAWORLD (Bahamas) Limited come from?
All FDA import refusal data for ONESPAWORLD (Bahamas) Limited 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.