INNOTHERA LABORATORIES
⚠️ High Risk
FEI: 3027369957 • Jiutepec • MEXICO
FEI Number
3027369957
Location
Jiutepec
Country
MEXICOAddress
Calle 13 Este No 5 Civa, Morelos, Jiutepec, , 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
Frequently Asked Questions
What is INNOTHERA LABORATORIES's FDA import refusal history?
INNOTHERA LABORATORIES (FEI: 3027369957) has 2 FDA import refusal record(s) in our database, spanning from 9/16/2025 to 9/16/2025.
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. INNOTHERA LABORATORIES's FEI number is 3027369957.
What types of violations has INNOTHERA LABORATORIES received?
INNOTHERA LABORATORIES 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 INNOTHERA LABORATORIES come from?
All FDA import refusal data for INNOTHERA LABORATORIES 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.