Farmacia Drogueria San Jorge Ltda
⚠️ Moderate Risk
FEI: 3009526643 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3009526643
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 2 14 34, , Cali, Valle Del Cauca, Colombia
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Farmacia Drogueria San Jorge Ltda's FDA import refusal history?
Farmacia Drogueria San Jorge Ltda (FEI: 3009526643) has 1 FDA import refusal record(s) in our database, spanning from 8/10/2012 to 8/10/2012.
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. Farmacia Drogueria San Jorge Ltda's FEI number is 3009526643.
What types of violations has Farmacia Drogueria San Jorge Ltda received?
Farmacia Drogueria San Jorge Ltda has been cited for 2 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 Farmacia Drogueria San Jorge Ltda come from?
All FDA import refusal data for Farmacia Drogueria San Jorge Ltda 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.