Katherine Ortiz
⚠️ Moderate Risk
FEI: 3006246457 • Bogotabogota • COLOMBIA
FEI Number
3006246457
Location
Bogotabogota
Country
COLOMBIAAddress
Cr 53 C # 131a 10, , Bogotabogota, , 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2007 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | Florida District Office (FLA-DO) | |
| 5/24/2007 | 78EYCCATHETER, UPPER URINARY TRACT | Florida District Office (FLA-DO) | |
| 5/24/2007 | 65QCA01BACLOFEN (RELAXANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/24/2007 | 61NAC69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/24/2007 | 60QAY07LIDOCAINE | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Katherine Ortiz's FDA import refusal history?
Katherine Ortiz (FEI: 3006246457) has 5 FDA import refusal record(s) in our database, spanning from 5/24/2007 to 5/24/2007.
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. Katherine Ortiz's FEI number is 3006246457.
What types of violations has Katherine Ortiz received?
Katherine Ortiz 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 Katherine Ortiz come from?
All FDA import refusal data for Katherine Ortiz 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.