Becton Dickinson De Mexico
⚠️ Moderate Risk
FEI: 1000232458 • Cuautitlan Izcalli, Mexico • MEXICO
FEI Number
1000232458
Location
Cuautitlan Izcalli, Mexico
Country
MEXICOAddress
Autopista 55 59 99 8400 K.M. 37.5, Cuautitlan Izcalli, Cuautitlan Izcalli, Mexico, 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
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.
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).
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.
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).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2019 | 80FMFSYRINGE, PISTON | Division of Southwest Imports (DSWI) | |
| 7/9/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 7/1/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 6/12/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 6/12/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 5/20/2015 | 80FMFSYRINGE, PISTON | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 5/4/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 4/29/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 4/16/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 4/8/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 4/7/2015 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 3/27/2015 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 3/27/2015 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2015 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2015 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/22/2014 | 64GCC07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2014 | 80FMFSYRINGE, PISTON | Southwest Import District Office (SWI-DO) | |
| 7/3/2007 | 80KZHINTRODUCER, SYRINGE NEEDLE | Cincinnati District Office (CIN-DO) | |
| 5/23/2007 | 80MEGSYRINGE, ANTISTICK | 3260NO ENGLISH | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Becton Dickinson De Mexico's FDA import refusal history?
Becton Dickinson De Mexico (FEI: 1000232458) has 19 FDA import refusal record(s) in our database, spanning from 5/23/2007 to 7/3/2019.
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. Becton Dickinson De Mexico's FEI number is 1000232458.
What types of violations has Becton Dickinson De Mexico received?
Becton Dickinson De Mexico has been cited for 9 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 Becton Dickinson De Mexico come from?
All FDA import refusal data for Becton Dickinson De Mexico 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.