Laboratorios Kener, SA de CV
⚠️ High Risk
FEI: 3006763268 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3006763268
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Torre Poniente, Oficina 7a, Bosques De Las Lomas, Calle Paseo De Los Tamarindos 400; Col. Bosque De Las Lomas, Cuajimalpa De Morelos, Ciudad De Mexico, Ciudad de Mexico, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2024 | 61XDB99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 65PCL99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 64LCJ05BETAMETHASONE BENZOATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 56BCR05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 65CCC99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2024 | 66BCY99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/29/2020 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 62LDA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 54ACA05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 62KDA11NITAZOXANIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 56ECA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 61JCA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2016 | 54ABA01VITAMIN A | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2016 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2016 | 62GAA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2016 | 62GAA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2016 | 62GAA94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/29/2016 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 56GCO99ANTIFUNGAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2010 | 56BYY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/10/2010 | 61GCY57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laboratorios Kener, SA de CV's FDA import refusal history?
Laboratorios Kener, SA de CV (FEI: 3006763268) has 25 FDA import refusal record(s) in our database, spanning from 5/10/2010 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 Kener, SA de CV's FEI number is 3006763268.
What types of violations has Laboratorios Kener, SA de CV received?
Laboratorios Kener, SA de CV has been cited for 1 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 Kener, SA de CV come from?
All FDA import refusal data for Laboratorios Kener, 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.