Smiths Healthcare Manufacturing SA de CV
⚠️ High Risk
FEI: 3002963732 • Ciudad Apodaca, Nuevo Leon • MEXICO
FEI
FEI Number
3002963732
📍
Location
Ciudad Apodaca, Nuevo Leon
🇲🇽
Country
MEXICO🏢
Address
Carretera Miguel Aleman Km 21.7, Zona Industrial Parque Industrial Monterrey, Apodaca, Ciudad Apodaca, Nuevo Leon, Mexico
High Risk
FDA Import Risk Assessment
66.1
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
549
Total Refusals
2
Unique Violations
10/28/2011
Latest Refusal
5/18/2011
Earliest Refusal
Score Breakdown
Violation Severity
65.2×40%
Refusal Volume
100.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
508437×
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.
118140×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 10/28/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 8/22/2011 | 85MQENEEDLE, ASSISTED REPRODUCTION | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BYHDRAIN, TEE (WATER TRAP) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 85MQENEEDLE, ASSISTED REPRODUCTION | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/22/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 78FPDTUBE, FEEDING | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 78FPDTUBE, FEEDING | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 78FPDTUBE, FEEDING | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 78FPDTUBE, FEEDING | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BYHDRAIN, TEE (WATER TRAP) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BYHDRAIN, TEE (WATER TRAP) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/19/2011 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 85MQENEEDLE, ASSISTED REPRODUCTION | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73OFRTRACHEOBRONCHIAL SUCTION CATHETER KIT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FFATUBE, DRAINAGE, SUPRAPUBIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 78FPDTUBE, FEEDING | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BYHDRAIN, TEE (WATER TRAP) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 85MQENEEDLE, ASSISTED REPRODUCTION | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/9/2011 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Smiths Healthcare Manufacturing SA de CV's FDA import refusal history?
Smiths Healthcare Manufacturing SA de CV (FEI: 3002963732) has 549 FDA import refusal record(s) in our database, spanning from 5/18/2011 to 10/28/2011.
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. Smiths Healthcare Manufacturing SA de CV's FEI number is 3002963732.
What types of violations has Smiths Healthcare Manufacturing SA de CV received?
Smiths Healthcare Manufacturing SA de CV 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 Smiths Healthcare Manufacturing SA de CV come from?
All FDA import refusal data for Smiths Healthcare Manufacturing SA de CV 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.