CCT Critical Care Technologies, S.R.L.
⚠️ Moderate Risk
FEI: 3003081151 • San Cristobal • DOMINICAN REPUBLIC
FEI Number
3003081151
Location
San Cristobal
Country
DOMINICAN REPUBLICAddress
Parque Industrial Itabo, Km. 18.5 Carr. Sanchez, Haina, San Cristobal, , Dominican Republic
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
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.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2023 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 11/17/2022 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/17/2022 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/25/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/23/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/22/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/3/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is CCT Critical Care Technologies, S.R.L.'s FDA import refusal history?
CCT Critical Care Technologies, S.R.L. (FEI: 3003081151) has 7 FDA import refusal record(s) in our database, spanning from 8/3/2020 to 2/2/2023.
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. CCT Critical Care Technologies, S.R.L.'s FEI number is 3003081151.
What types of violations has CCT Critical Care Technologies, S.R.L. received?
CCT Critical Care Technologies, S.R.L. has been cited for 2 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 CCT Critical Care Technologies, S.R.L. come from?
All FDA import refusal data for CCT Critical Care Technologies, S.R.L. 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.