Productos Roche S.A. de C. V.
⚠️ Moderate Risk
FEI: 3003502861 • Toluca de Lerdo, Edomex • MEXICO
FEI Number
3003502861
Location
Toluca de Lerdo, Edomex
Country
MEXICOAddress
Isidro Fabela Norte No. 1536, , Toluca de Lerdo, Edomex, 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
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).
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).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2019 | 56YDY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2019 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 64TCA04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2011 | 61MCK06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/9/2010 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/1/2007 | 54ACC90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 7/16/2007 | 61GDL57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 62GDA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/26/2003 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | Chicago District Office (CHI-DO) | |
| 10/22/2002 | 64LDK27FLUOCINOLONE ACETONIDE (GLUCOCORTICOID) | Chicago District Office (CHI-DO) | |
| 10/22/2002 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Productos Roche S.A. de C. V.'s FDA import refusal history?
Productos Roche S.A. de C. V. (FEI: 3003502861) has 13 FDA import refusal record(s) in our database, spanning from 10/22/2002 to 7/26/2019.
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. Productos Roche S.A. de C. V.'s FEI number is 3003502861.
What types of violations has Productos Roche S.A. de C. V. received?
Productos Roche 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 Roche S.A. de C. V. come from?
All FDA import refusal data for Productos Roche 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.