Inovaker Lab SA de CV
⚠️ Moderate Risk
FEI: 3009028673 • Monterrey, Nuevo Leon • MEXICO
FEI Number
3009028673
Location
Monterrey, Nuevo Leon
Country
MEXICOAddress
Calle Luis Quintanar 105, Col. Bella Vista, Monterrey, Monterrey, Nuevo Leon, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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 |
|---|---|---|---|
| 10/1/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 9/27/2020 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/27/2020 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/27/2020 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/27/2020 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Inovaker Lab SA de CV's FDA import refusal history?
Inovaker Lab SA de CV (FEI: 3009028673) has 5 FDA import refusal record(s) in our database, spanning from 9/27/2020 to 10/1/2020.
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. Inovaker Lab SA de CV's FEI number is 3009028673.
What types of violations has Inovaker Lab SA de CV received?
Inovaker Lab SA de CV 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 Inovaker Lab SA de CV come from?
All FDA import refusal data for Inovaker Lab 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.