SOLARA S.A. DE C,V
⚠️ High Risk
FEI: 3012616004 • San Mateo Atenc • MEXICO
FEI Number
3012616004
Location
San Mateo Atenc
Country
MEXICOAddress
5 de Mayo 307-A, Col. RE, San Mateo Atenc, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2024 | 62UCA08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 61ECC08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 54ABA01VITAMIN A | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is SOLARA S.A. DE C,V's FDA import refusal history?
SOLARA S.A. DE C,V (FEI: 3012616004) has 5 FDA import refusal record(s) in our database, spanning from 8/24/2016 to 2/27/2024.
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. SOLARA S.A. DE C,V's FEI number is 3012616004.
What types of violations has SOLARA S.A. DE C,V received?
SOLARA S.A. DE C,V 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 SOLARA S.A. DE C,V come from?
All FDA import refusal data for SOLARA S.A. DE C,V 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.