Productos Cientificos Sa De C.V.
⚠️ Moderate Risk
FEI: 3012204793 • Benito Juarez • MEXICO
FEI Number
3012204793
Location
Benito Juarez
Country
MEXICOAddress
1046 Col. Del Valle Centro, , Benito Juarez, , 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
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 |
|---|---|---|---|
| 12/2/2021 | 61HCY43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Productos Cientificos Sa De C.V.'s FDA import refusal history?
Productos Cientificos Sa De C.V. (FEI: 3012204793) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2021 to 12/2/2021.
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. Productos Cientificos Sa De C.V.'s FEI number is 3012204793.
What types of violations has Productos Cientificos Sa De C.V. received?
Productos Cientificos Sa 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 Productos Cientificos Sa De C.V. come from?
All FDA import refusal data for Productos Cientificos Sa 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.