LABORATORIOS RUSSEK S DE RL DE
⚠️ High Risk
FEI: 3012527427 • Tlalnepantla • MEXICO
FEI Number
3012527427
Location
Tlalnepantla
Country
MEXICOAddress
Calz Las Armas NO 110 C, , Tlalnepantla, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2024 | 62KCA11NITAZOXANIDE | Division of Southeast Imports (DSEI) | |
| 10/2/2024 | 61XDA34TERFENADINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2023 | 61WCY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 62KCA11NITAZOXANIDE | Division of Southeast Imports (DSEI) | |
| 11/30/2020 | 60QDY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2019 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 62GDA52NIMAZONE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 62GAA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 61WCA52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 61WCO52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2017 | 61PCY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2017 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS RUSSEK S DE RL DE's FDA import refusal history?
LABORATORIOS RUSSEK S DE RL DE (FEI: 3012527427) has 13 FDA import refusal record(s) in our database, spanning from 1/23/2017 to 11/14/2024.
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. LABORATORIOS RUSSEK S DE RL DE's FEI number is 3012527427.
What types of violations has LABORATORIOS RUSSEK S DE RL DE received?
LABORATORIOS RUSSEK S DE RL DE 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 LABORATORIOS RUSSEK S DE RL DE come from?
All FDA import refusal data for LABORATORIOS RUSSEK S DE RL DE 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.