Productos Para El Cuidado De La Salud
⚠️ High Risk
FEI: 1000237915 • Nogales • MEXICO
FEI Number
1000237915
Location
Nogales
Country
MEXICOAddress
Carretera Internacional KM. 6.5, Terrazas Del Cid, Nogales, , 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.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2025 | 78EZCCATHETER, COUDE | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 1/9/2024 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 9/25/2020 | 78FPDTUBE, FEEDING | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 1/23/2020 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/4/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/4/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/30/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/30/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/18/2019 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/3/2019 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/26/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/11/2019 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/20/2018 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/20/2018 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/29/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/28/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/20/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/20/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/2/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/29/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/25/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/17/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 7/27/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 5/14/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 5/3/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/5/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 126FAILS STD | Division of Southwest Imports (DSWI) |
| 3/28/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/22/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/16/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/16/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/16/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/16/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/15/2018 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/21/2017 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/25/2017 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/25/2017 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/25/2017 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 5/5/2017 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/7/2017 | 80KYXDISPENSER, LIQUID MEDICATION | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/5/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | Southwest Import District Office (SWI-DO) | |
| 10/5/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | Southwest Import District Office (SWI-DO) | |
| 7/22/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 7/22/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 7/22/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 7/22/2016 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/11/2015 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/4/2015 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 126FAILS STD | Division of Southwest Imports (DSWI) |
| 7/16/2015 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 5/19/2015 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 5/5/2015 | 78FEGTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 1/11/2011 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Productos Para El Cuidado De La Salud's FDA import refusal history?
Productos Para El Cuidado De La Salud (FEI: 1000237915) has 56 FDA import refusal record(s) in our database, spanning from 1/11/2011 to 5/7/2025.
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. Productos Para El Cuidado De La Salud's FEI number is 1000237915.
What types of violations has Productos Para El Cuidado De La Salud received?
Productos Para El Cuidado De La Salud has been cited for 5 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 Productos Para El Cuidado De La Salud come from?
All FDA import refusal data for Productos Para El Cuidado De La Salud 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.