Productos Medline, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004122598 • Nuevo Laredo, Tamaulipas • MEXICO
FEI Number
3004122598
Location
Nuevo Laredo, Tamaulipas
Country
MEXICOAddress
Center No. 106, Blvd. Trade; Parque Industrial Oradel, Nuevo Laredo, Tamaulipas, Mexico
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2012 | 74OESCARDIAC CATHETERIZATION KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/23/2012 | 74OEQANGIOGRAPHY/ANGIOPLASTY KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/10/2012 | 74OEZCARDIOVASCULAR PROCEDURE KIT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 1/9/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 1/6/2012 | 79MCYKIT, WOUND DRESSING | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 74OEQANGIOGRAPHY/ANGIOPLASTY KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79MCYKIT, WOUND DRESSING | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 1/6/2012 | 74OEQANGIOGRAPHY/ANGIOPLASTY KIT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 1/6/2012 | 74OESCARDIAC CATHETERIZATION KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 74OESCARDIAC CATHETERIZATION KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 74OESCARDIAC CATHETERIZATION KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 85OKVOBSTETRICAL KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 85MLSLABOR AND DELIVERY KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79MCYKIT, WOUND DRESSING | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 74OESCARDIAC CATHETERIZATION KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79MCYKIT, WOUND DRESSING | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79LROKIT, SURGICAL - GENERAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/1/2011 | 62FBK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 80FMEGOWN, EXAMINATION | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 79GEMGAUZE, ABSORBABLE | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 79KKXDRAPE, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 79FXNTAPE, CAMERA, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 78FCMTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 79GEPSPONGE, SYNTHETIC, EXTERNAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/17/2006 | 80FMFSYRINGE, PISTON | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FYFCAP, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79BWPSHOE AND SHOE COVER, CONDUCTIVE | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 84GYBMEDIA, ELECTROCONDUCTIVE | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FMEGOWN, EXAMINATION | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FXXMASK, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FRODRESSING, WOUND, DRUG | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FQMBANDAGE, ELASTIC | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79KKXDRAPE, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GEMGAUZE, ABSORBABLE | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 76EMHFORCEPS, RONGEUR, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79LROKIT, SURGICAL - GENERAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GAXTOURNIQUET, NONPNEUMATIC | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GECBRUSH, SCRUB, OPERATING-ROOM | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79LRPTRAY, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 76EMHFORCEPS, RONGEUR, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79HXDCLAMP | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FXNTAPE, CAMERA, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GEPSPONGE, SYNTHETIC, EXTERNAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FMFSYRINGE, PISTON | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 78FCMTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80KYZSYRINGE, IRRIGATING | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 78FCMTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FXNTAPE, CAMERA, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GEPSPONGE, SYNTHETIC, EXTERNAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 76EMHFORCEPS, RONGEUR, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FMFSYRINGE, PISTON | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79BWPSHOE AND SHOE COVER, CONDUCTIVE | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FMEGOWN, EXAMINATION | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FXXMASK, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 80FQMBANDAGE, ELASTIC | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 76EFNCOTTON, ROLL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79FRODRESSING, WOUND, DRUG | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79KKXDRAPE, SURGICAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 79GEPSPONGE, SYNTHETIC, EXTERNAL | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Productos Medline, S.A. de C.V.'s FDA import refusal history?
Productos Medline, S.A. de C.V. (FEI: 3004122598) has 65 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 2/23/2012.
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 Medline, S.A. de C.V.'s FEI number is 3004122598.
What types of violations has Productos Medline, S.A. de C.V. received?
Productos Medline, S.A. de C.V. has been cited for 4 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 Medline, S.A. de C.V. come from?
All FDA import refusal data for Productos Medline, S.A. de C.V. 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.