Fenwal International, Inc.
⚠️ Moderate Risk
FEI: 3002806457 • Bajos De Haina, San Cristobal • DOMINICAN REPUBLIC
FEI Number
3002806457
Location
Bajos De Haina, San Cristobal
Country
DOMINICAN REPUBLICAddress
Parque Industrial Itabo Zona Franca Ind. De S.C, Carretera Sanchez Km 18 1/2 Bldgs. 48-50, Bajos De 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2020 | 80LWEBONE MARROW COLLECTION/TRANSFUSION KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/23/2019 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/23/2019 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/28/2017 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/28/2017 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/28/2017 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/12/2017 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/6/2017 | 80LWEBONE MARROW COLLECTION/TRANSFUSION KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/12/2016 | 81KSRCONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 508NO 510(K) | San Juan District Office (SJN-DO) |
| 5/21/2014 | 80BRZSET, BLOOD TRANSFUSION | 341REGISTERED | San Juan District Office (SJN-DO) |
| 2/21/2002 | 81GKTSEPARATOR, AUTOMATED, BLOOD CELL | 508NO 510(K) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Fenwal International, Inc.'s FDA import refusal history?
Fenwal International, Inc. (FEI: 3002806457) has 11 FDA import refusal record(s) in our database, spanning from 2/21/2002 to 2/7/2020.
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. Fenwal International, Inc.'s FEI number is 3002806457.
What types of violations has Fenwal International, Inc. received?
Fenwal International, Inc. 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 Fenwal International, Inc. come from?
All FDA import refusal data for Fenwal International, 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.