MARIA STELLA TORRES GUERRA
⚠️ Moderate Risk
FEI: 3017524287 • Medellin, Antioquia • COLOMBIA
FEI Number
3017524287
Location
Medellin, Antioquia
Country
COLOMBIAAddress
Calle 38 75 115, Sur, Medellin, Antioquia, 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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 12/22/2020 | 56CQY27CEPHALEXIN (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 62FQY08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 60ZQY13FLURALANER (ANTIPARASITIC) | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 64LQY60TRIAMCINOLONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 66VOY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 62FQY08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 66VOY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/22/2020 | 62FQY08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MARIA STELLA TORRES GUERRA's FDA import refusal history?
MARIA STELLA TORRES GUERRA (FEI: 3017524287) has 8 FDA import refusal record(s) in our database, spanning from 12/22/2020 to 12/22/2020.
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. MARIA STELLA TORRES GUERRA's FEI number is 3017524287.
What types of violations has MARIA STELLA TORRES GUERRA received?
MARIA STELLA TORRES GUERRA 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 MARIA STELLA TORRES GUERRA come from?
All FDA import refusal data for MARIA STELLA TORRES GUERRA 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.