International Biotech Factory, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3017526425 • Ciudad Santa Catarina, Nuevo Leon • MEXICO
FEI Number
3017526425
Location
Ciudad Santa Catarina, Nuevo Leon
Country
MEXICOAddress
Solidaridad No. 2008, Col. Unidad Nacional Ii, Santa Catarina, Ciudad Santa Catarina, 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).
Refusal History
Frequently Asked Questions
What is International Biotech Factory, S.A. de C.V.'s FDA import refusal history?
International Biotech Factory, S.A. de C.V. (FEI: 3017526425) has 2 FDA import refusal record(s) in our database, spanning from 2/5/2021 to 2/5/2021.
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. International Biotech Factory, S.A. de C.V.'s FEI number is 3017526425.
What types of violations has International Biotech Factory, S.A. de C.V. received?
International Biotech Factory, S.A. de C.V. 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 International Biotech Factory, S.A. de C.V. come from?
All FDA import refusal data for International Biotech Factory, 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.