ROPSOHN THERAPEUTICS LTDA.
⚠️ Moderate Risk
FEI: 3012556153 • Bogota • COLOMBIA
FEI Number
3012556153
Location
Bogota
Country
COLOMBIAAddress
Carrera 13 No. 50 78, , Bogota, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
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
Frequently Asked Questions
What is ROPSOHN THERAPEUTICS LTDA.'s FDA import refusal history?
ROPSOHN THERAPEUTICS LTDA. (FEI: 3012556153) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2016 to 9/9/2016.
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. ROPSOHN THERAPEUTICS LTDA.'s FEI number is 3012556153.
What types of violations has ROPSOHN THERAPEUTICS LTDA. received?
ROPSOHN THERAPEUTICS LTDA. has been cited for 3 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 ROPSOHN THERAPEUTICS LTDA. come from?
All FDA import refusal data for ROPSOHN THERAPEUTICS 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.