Laboratorios Zeyco S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004109292 • Zapopan, Jalisco • MEXICO
FEI Number
3004109292
Location
Zapopan, Jalisco
Country
MEXICOAddress
Calle Camino A Santa Ana Tepetitlan Santa Ana Tepetitlan 2230, Zapopan, Zapopan, Jalisco, 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/7/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/7/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/7/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/16/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/24/2011 | 76ECFSTERILIZER, DRY HEAT, ENDODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 60QCJ67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 60QDL67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios Zeyco S.A. de C.V.'s FDA import refusal history?
Laboratorios Zeyco S.A. de C.V. (FEI: 3004109292) has 10 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 10/7/2021.
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 Zeyco S.A. de C.V.'s FEI number is 3004109292.
What types of violations has Laboratorios Zeyco S.A. de C.V. received?
Laboratorios Zeyco S.A. de C.V. 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 Zeyco S.A. de C.V. come from?
All FDA import refusal data for Laboratorios Zeyco 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.