BIO SYSTEMS DE MEXICO SA DE CV
⚠️ Moderate Risk
FEI: 3017084983 • Miguel Hidalgo • MEXICO
FEI Number
3017084983
Location
Miguel Hidalgo
Country
MEXICOAddress
Ingenieros Militares 7021 Cp, Pmoa; Cazcapot Zalco, Miguel Hidalgo, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 11/16/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 11/16/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is BIO SYSTEMS DE MEXICO SA DE CV's FDA import refusal history?
BIO SYSTEMS DE MEXICO SA DE CV (FEI: 3017084983) has 3 FDA import refusal record(s) in our database, spanning from 11/16/2020 to 11/16/2020.
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. BIO SYSTEMS DE MEXICO SA DE CV's FEI number is 3017084983.
What types of violations has BIO SYSTEMS DE MEXICO SA DE CV received?
BIO SYSTEMS DE MEXICO 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 BIO SYSTEMS DE MEXICO SA DE CV come from?
All FDA import refusal data for BIO SYSTEMS DE MEXICO 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.