Davol Surgical Innovations
⚠️ High Risk
FEI: 3001436772 • Cd. Juarez, Chihuahua • MEXICO
FEI Number
3001436772
Location
Cd. Juarez, Chihuahua
Country
MEXICOAddress
Ave. Roberto Fierro No. 6408, Parque Industrial Aeropuerto, Cd. Juarez, Chihuahua, Mexico
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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 |
|---|---|---|---|
| 7/26/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/23/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/23/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/23/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/23/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/26/2021 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/26/2021 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/8/2021 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/8/2021 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/23/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 11/23/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/13/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 8/13/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 3/4/2020 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON STERILE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/4/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 2/18/2020 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2019 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/7/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/2/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/28/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/28/2019 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/28/2019 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/28/2019 | 78OHRCATHETER CARE TRAY | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/8/2019 | 78EZDCATHETER, STRAIGHT | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/29/2017 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/29/2017 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/29/2017 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/29/2017 | 78KODCATHETER, UROLOGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/28/2007 | 78GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Davol Surgical Innovations's FDA import refusal history?
Davol Surgical Innovations (FEI: 3001436772) has 69 FDA import refusal record(s) in our database, spanning from 8/28/2007 to 7/26/2021.
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. Davol Surgical Innovations's FEI number is 3001436772.
What types of violations has Davol Surgical Innovations received?
Davol Surgical Innovations 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 Davol Surgical Innovations come from?
All FDA import refusal data for Davol Surgical Innovations 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.