PROSANA DISTRIBUCIONES SA DE CV
⚠️ Moderate Risk
FEI: 3011473501 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3011473501
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Oriente 225 97-1, Col. Agricola Oriental, Iztacalco, Ciudad De Mexico, Ciudad de Mexico, 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 |
|---|---|---|---|
| 3/12/2018 | 36CYY04HONEY | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/12/2018 | 36CYY04HONEY | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/8/2017 | 62UDJ99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/8/2017 | 62UDJ99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/8/2017 | 62UDJ99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is PROSANA DISTRIBUCIONES SA DE CV's FDA import refusal history?
PROSANA DISTRIBUCIONES SA DE CV (FEI: 3011473501) has 5 FDA import refusal record(s) in our database, spanning from 8/8/2017 to 3/12/2018.
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. PROSANA DISTRIBUCIONES SA DE CV's FEI number is 3011473501.
What types of violations has PROSANA DISTRIBUCIONES SA DE CV received?
PROSANA DISTRIBUCIONES 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 PROSANA DISTRIBUCIONES SA DE CV come from?
All FDA import refusal data for PROSANA DISTRIBUCIONES 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.