Rotech Subsea Ltd
⚠️ Moderate Risk
FEI: 3005090632 • Aberdeen, FN • UNITED KINGDOM
FEI Number
3005090632
Location
Aberdeen, FN
Country
UNITED KINGDOMAddress
Rotech House, , Aberdeen, FN, United Kingdom
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
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 |
|---|---|---|---|
| 10/25/2022 | 77EWDPROTECTOR, HEARING (INSERT) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 10/25/2022 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 10/25/2022 | 65FAY06WATER, PURIFIED (EYEWASH) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 10/25/2022 | 79OHOFIRST AID KIT WITHOUT DRUG | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Rotech Subsea Ltd's FDA import refusal history?
Rotech Subsea Ltd (FEI: 3005090632) has 4 FDA import refusal record(s) in our database, spanning from 10/25/2022 to 10/25/2022.
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. Rotech Subsea Ltd's FEI number is 3005090632.
What types of violations has Rotech Subsea Ltd received?
Rotech Subsea Ltd has been cited for 1 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 Rotech Subsea Ltd come from?
All FDA import refusal data for Rotech Subsea Ltd 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.